Trial Outcomes & Findings for Immune Responses With Reduxium (NCT NCT04525456)
NCT ID: NCT04525456
Last Updated: 2022-05-27
Results Overview
Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Results posted on
2022-05-27
Participant Flow
Recruitment happened between October 7, 2020 and January 27, 2021 at National University Hospital (NUH) in Singapore.
Participant milestones
| Measure |
Reduxium
1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days
Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
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|---|---|
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Age, Continuous
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32.4 years
STANDARD_DEVIATION 5.4 • n=20 Participants
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Sex: Female, Male
Female
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14 Participants
n=20 Participants
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Sex: Female, Male
Male
|
6 Participants
n=20 Participants
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Region of Enrollment
Singapore
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20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baselineBlood tests of T cell subsets and phenotypes utilising groups of labelled antibodies
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
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|---|---|
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Th1/Th17 cells
|
4.56 percentage of cells
Standard Deviation 3.80
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Total T cells
|
60.53 percentage of cells
Standard Deviation 9.24
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Total T cells
|
60 percentage of cells
Standard Deviation 10.27
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Total T cells
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59.29 percentage of cells
Standard Deviation 9.44
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Total T cells
|
56.52 percentage of cells
Standard Deviation 11.88
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Total T cells
|
57.44 percentage of cells
Standard Deviation 12.75
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Total T cells
|
58.54 percentage of cells
Standard Deviation 10.23
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Total T cells
|
58.54 percentage of cells
Standard Deviation 11.09
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Total CD8 (cluster of differentiation 8)+ T cells
|
34.08 percentage of cells
Standard Deviation 8.98
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Total CD8+ T cells
|
35.08 percentage of cells
Standard Deviation 8.71
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Total CD8+ T cells
|
35.08 percentage of cells
Standard Deviation 9.19
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Total CD8+ T cells
|
34.46 percentage of cells
Standard Deviation 9.34
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Total CD8+ T cells
|
35.30 percentage of cells
Standard Deviation 8.88
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Total CD8+ T cells
|
34.68 percentage of cells
Standard Deviation 9.93
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Total CD8+ T cells
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34.49 percentage of cells
Standard Deviation 9.56
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Exhausted CD8+ T cells
|
1.81 percentage of cells
Standard Deviation 1.15
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Exhausted CD8+ T cells
|
2.06 percentage of cells
Standard Deviation 1.42
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Exhausted CD8+ T cells
|
2.03 percentage of cells
Standard Deviation 1.44
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Exhausted CD8+ T cells
|
1.61 percentage of cells
Standard Deviation 1.00
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Exhausted CD8+ T cells
|
1.78 percentage of cells
Standard Deviation 1.18
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Exhausted CD8+ T cells
|
2.00 percentage of cells
Standard Deviation 1.36
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Exhausted CD8+ T cells
|
1.88 percentage of cells
Standard Deviation 1.08
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Total CD4+ cells
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54.16 percentage of cells
Standard Deviation 10.98
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Total CD4+ cells
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53.57 percentage of cells
Standard Deviation 12.13
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Total CD4+ cells
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53.97 percentage of cells
Standard Deviation 11.34
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Total CD4+ cells
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53.34 percentage of cells
Standard Deviation 12.22
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Total CD4+ cells
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53.58 percentage of cells
Standard Deviation 10.85
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Total CD4+ cells
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54.79 percentage of cells
Standard Deviation 12.30
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Total CD4+ cells
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54.49 percentage of cells
Standard Deviation 12.54
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Exhausted CD4+ T cells
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11.30 percentage of cells
Standard Deviation 5.46
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 -Exhausted CD4+ T cells
|
11.93 percentage of cells
Standard Deviation 5.39
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 -Exhausted CD4+ T cells
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11.15 percentage of cells
Standard Deviation 4.49
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 -Exhausted CD4+ T cells
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10.87 percentage of cells
Standard Deviation 5.96
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 -Exhausted CD4+ T cells
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10.65 percentage of cells
Standard Deviation 5.15
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 -Exhausted CD4+ T cells
|
11.59 percentage of cells
Standard Deviation 5.76
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 -Exhausted CD4+ T cells
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11.27 percentage of cells
Standard Deviation 4.90
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline -Regulatory T cells (Tregs)
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6.32 percentage of cells
Standard Deviation 1.39
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Regulatory T cells (Tregs)
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6.95 percentage of cells
Standard Deviation 1.50
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Regulatory T cells (Tregs)
|
7.34 percentage of cells
Standard Deviation 1.80
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Regulatory T cells (Tregs)
|
6.49 percentage of cells
Standard Deviation 1.93
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Regulatory T cells (Tregs)
|
6.88 percentage of cells
Standard Deviation 1.90
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Regulatory T cells (Tregs)
|
6.81 percentage of cells
Standard Deviation 1.90
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Regulatory T cells (Tregs)
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7.05 percentage of cells
Standard Deviation 1.53
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - chemokine receptor 3 (CXCR3)-Chemokine receptor 6 (CCR6)+
|
1.02 percentage of cells
Standard Deviation 1.45
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - CXCR3-CCR6+
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1.24 percentage of cells
Standard Deviation 2.24
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - CXCR3-CCR6+
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1.09 percentage of cells
Standard Deviation 1.81
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - CXCR3-CCR6+
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1.60 percentage of cells
Standard Deviation 2.23
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - CXCR3-CCR6+
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1.34 percentage of cells
Standard Deviation 1.94
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - CXCR3-CCR6+
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1.32 percentage of cells
Standard Deviation 1.92
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - CXCR3-CCR6+
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1.09 percentage of cells
Standard Deviation 1.63
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - T helper (Th) 1/Th17 cells
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7.17 percentage of cells
Standard Deviation 5.19
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Th1/Th17 cells
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6.02 percentage of cells
Standard Deviation 5.48
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Th1/Th17 cells
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5.33 percentage of cells
Standard Deviation 5.12
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Th1/Th17 cells
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4.55 percentage of cells
Standard Deviation 3.92
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Th1/Th17 cells
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4.57 percentage of cells
Standard Deviation 3.67
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Th1/Th17 cells
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4.70 percentage of cells
Standard Deviation 3.69
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Th1 cells
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48.63 percentage of cells
Standard Deviation 24.93
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Th1 cells
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45.58 percentage of cells
Standard Deviation 30.23
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Th1 cells
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44.85 percentage of cells
Standard Deviation 31.63
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Th1 cells
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44.15 percentage of cells
Standard Deviation 31.98
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Th1 cells
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47.80 percentage of cells
Standard Deviation 33.09
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Th1 cells
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47.30 percentage of cells
Standard Deviation 30.82
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Th1 cells
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47.58 percentage of cells
Standard Deviation 32.12
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Th17 cells
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1.28 percentage of cells
Standard Deviation 0.80
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Th17 cells
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1.16 percentage of cells
Standard Deviation 0.91
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Th17 cells
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1.21 percentage of cells
Standard Deviation 0.99
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Th17 cells
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1.19 percentage of cells
Standard Deviation 1.07
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Th17 cells
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1.16 percentage of cells
Standard Deviation 1.16
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Th17 cells
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1.14 percentage of cells
Standard Deviation 0.84
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Th17 cells
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1.24 percentage of cells
Standard Deviation 1.22
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Th2 cells
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2.86 percentage of cells
Standard Deviation 1.75
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Th2 cells
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3.67 percentage of cells
Standard Deviation 2.28
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Th2 cells
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3.58 percentage of cells
Standard Deviation 2.13
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Th2 cells
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3.46 percentage of cells
Standard Deviation 1.97
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Th2 cells
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3.56 percentage of cells
Standard Deviation 1.94
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Th2 cells
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3.82 percentage of cells
Standard Deviation 2.33
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Th2 cells
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4.05 percentage of cells
Standard Deviation 2.23
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - T follicular helper cells (Tfh)
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13.75 percentage of cells
Standard Deviation 2.67
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - T follicular helper cells (Tfh)
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12.75 percentage of cells
Standard Deviation 3.52
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - T follicular helper cells (Tfh)
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12.02 percentage of cells
Standard Deviation 3.48
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - T follicular helper cells (Tfh)
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12.40 percentage of cells
Standard Deviation 3.83
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - T follicular helper cells (Tfh)
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12.22 percentage of cells
Standard Deviation 3.16
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - T follicular helper cells (Tfh)
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12.33 percentage of cells
Standard Deviation 3.50
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - T follicular helper cells (Tfh)
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11.58 percentage of cells
Standard Deviation 4.92
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Activated Tfh (Inducible T-cell Costimulator (ICOS+))
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0.50 percentage of cells
Standard Deviation 0.24
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Activated Tfh (ICOS+)
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0.45 percentage of cells
Standard Deviation 0.24
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Activated Tfh (ICOS+)
|
0.44 percentage of cells
Standard Deviation 0.27
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Activated Tfh (ICOS+)
|
0.38 percentage of cells
Standard Deviation 0.22
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Activated Tfh (ICOS+)
|
0.40 percentage of cells
Standard Deviation 0.23
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Activated Tfh (ICOS+)
|
0.47 percentage of cells
Standard Deviation 0.26
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Activated Tfh (ICOS+)
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0.48 percentage of cells
Standard Deviation 0.32
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Activated Tfh (Programmed cell death protein 1 (PD-1+))
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2.30 percentage of cells
Standard Deviation 0.84
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Activated Tfh (PD-1+)
|
2.25 percentage of cells
Standard Deviation 0.88
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Activated Tfh (PD-1+)
|
2.08 percentage of cells
Standard Deviation 1.01
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Activated Tfh (PD-1+)
|
2.01 percentage of cells
Standard Deviation 0.85
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Activated Tfh (PD-1+)
|
2.08 percentage of cells
Standard Deviation 0.85
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Activated Tfh (PD-1+)
|
2.20 percentage of cells
Standard Deviation 0.91
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Activated Tfh (PD-1+)
|
2.18 percentage of cells
Standard Deviation 1.16
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Activated Tfh (ICOS+PD-1+)
|
1.18 percentage of cells
Standard Deviation 0.67
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Activated Tfh (ICOS+PD-1+)
|
1.17 percentage of cells
Standard Deviation 0.58
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Activated Tfh (ICOS+PD-1+)
|
1.18 percentage of cells
Standard Deviation 0.60
|
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Activated Tfh (ICOS+PD-1+)
|
1.00 percentage of cells
Standard Deviation 0.49
|
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Activated Tfh (ICOS+PD-1+)
|
1.08 percentage of cells
Standard Deviation 0.46
|
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Activated Tfh (ICOS+PD-1+)
|
1.32 percentage of cells
Standard Deviation 0.89
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Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Activated Tfh (ICOS+PD-1+)
|
1.33 percentage of cells
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baselinePopulation: healthy participants
Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Total B cells
|
17.44 percentage of cells
Standard Deviation 6.89
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Total B cells
|
21.09 percentage of cells
Standard Deviation 12.68
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Total B cells
|
18.64 percentage of cells
Standard Deviation 7.32
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Total B cells
|
19.84 percentage of cells
Standard Deviation 10.33
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Total B cells
|
20.70 percentage of cells
Standard Deviation 9.28
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Total B cells
|
20.48 percentage of cells
Standard Deviation 8.92
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Total B cells
|
22.05 percentage of cells
Standard Deviation 10.99
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Memory B cells (MBCs)
|
7.47 percentage of cells
Standard Deviation 3.18
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Memory B cells (MBCs)
|
7.34 percentage of cells
Standard Deviation 3.08
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Memory B cells (MBCs)
|
7.63 percentage of cells
Standard Deviation 3.91
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Memory B cells (MBCs)
|
7.44 percentage of cells
Standard Deviation 3.46
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Memory B cells (MBCs)
|
7.17 percentage of cells
Standard Deviation 2.93
|
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Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Memory B cells (MBCs)
|
7.53 percentage of cells
Standard Deviation 3.38
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Memory B cells (MBCs)
|
7.66 percentage of cells
Standard Deviation 3.68
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Classical MBCs
|
1.24 percentage of cells
Standard Deviation 0.78
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Classical MBCs
|
0.96 percentage of cells
Standard Deviation 0.55
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Classical MBCs
|
1.06 percentage of cells
Standard Deviation 0.69
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Classical MBCs
|
1.15 percentage of cells
Standard Deviation 0.60
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Classical MBCs
|
0.90 percentage of cells
Standard Deviation 0.48
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Classical MBCs
|
0.91 percentage of cells
Standard Deviation 0.53
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Classical MBCs
|
0.93 percentage of cells
Standard Deviation 0.57
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Activated MBCs
|
6.28 percentage of cells
Standard Deviation 2.78
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Activated MBCs
|
6.37 percentage of cells
Standard Deviation 2.79
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Activated MBCs
|
6.59 percentage of cells
Standard Deviation 3.69
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Activated MBCs
|
6.46 percentage of cells
Standard Deviation 3.15
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Activated MBCs
|
6.25 percentage of cells
Standard Deviation 2.69
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Activated MBCs
|
6.61 percentage of cells
Standard Deviation 3.09
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Activated MBCs
|
6.71 percentage of cells
Standard Deviation 3.38
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Tissue-like MBCs
|
1.27 percentage of cells
Standard Deviation 0.90
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Tissue-like MBCs
|
1.01 percentage of cells
Standard Deviation 0.62
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Tissue-like MBCs
|
1.09 percentage of cells
Standard Deviation 0.69
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Tissue-like MBCs
|
1.04 percentage of cells
Standard Deviation 0.63
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Tissue-like MBCs
|
0.96 percentage of cells
Standard Deviation 0.56
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Tissue-like MBCs
|
0.95 percentage of cells
Standard Deviation 0.54
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Tissue-like MBCs
|
0.99 percentage of cells
Standard Deviation 0.60
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Switched B cells
|
1.58 percentage of cells
Standard Deviation 1.24
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Switched B cells
|
1.23 percentage of cells
Standard Deviation 1.21
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Switched B cells
|
1.39 percentage of cells
Standard Deviation 1.21
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Switched B cells
|
1.33 percentage of cells
Standard Deviation 1.12
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Switched B cells
|
1.17 percentage of cells
Standard Deviation 1.06
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Switched B cells
|
1.35 percentage of cells
Standard Deviation 1.13
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Switched B cells
|
1.75 percentage of cells
Standard Deviation 2.15
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Unswitched B cells
|
7.96 percentage of cells
Standard Deviation 3.37
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Unswitched B cells
|
7.76 percentage of cells
Standard Deviation 3.26
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Unswitched B cells
|
8.16 percentage of cells
Standard Deviation 4.27
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Unswitched B cells
|
7.90 percentage of cells
Standard Deviation 3.60
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Unswitched B cells
|
7.58 percentage of cells
Standard Deviation 3.07
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Unswitched B cells
|
7.98 percentage of cells
Standard Deviation 3.52
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Unswitched B cells
|
8.11 percentage of cells
Standard Deviation 3.83
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Naïve B cells
|
4.74 percentage of cells
Standard Deviation 2.61
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Naïve B cells
|
5.13 percentage of cells
Standard Deviation 3.00
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Naïve B cells
|
5.02 percentage of cells
Standard Deviation 3.02
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Naïve B cells
|
4.85 percentage of cells
Standard Deviation 3.07
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Naïve B cells
|
4.97 percentage of cells
Standard Deviation 3.10
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Naïve B cells
|
5.28 percentage of cells
Standard Deviation 3.18
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Naïve B cells
|
5.55 percentage of cells
Standard Deviation 3.41
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Plasmablasts
|
5.38 percentage of cells
Standard Deviation 3.63
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Plasmablasts
|
4.67 percentage of cells
Standard Deviation 3.79
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Plasmablasts
|
4.85 percentage of cells
Standard Deviation 3.68
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Plasmablasts
|
5.12 percentage of cells
Standard Deviation 3.89
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Plasmablasts
|
4.66 percentage of cells
Standard Deviation 3.53
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Plasmablasts
|
4.21 percentage of cells
Standard Deviation 3.08
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Plasmablasts
|
4.33 percentage of cells
Standard Deviation 3.26
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Baseline - Exhausted B cells
|
3.13 percentage of cells
Standard Deviation 1.83
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 3 - Exhausted B cells
|
2.36 percentage of cells
Standard Deviation 1.48
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 4 - Exhausted B cells
|
2.68 percentage of cells
Standard Deviation 1.88
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 5 - Exhausted B cells
|
2.71 percentage of cells
Standard Deviation 1.50
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 6 - Exhausted B cells
|
2.25 percentage of cells
Standard Deviation 1.22
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 7 - Exhausted B cells
|
2.45 percentage of cells
Standard Deviation 1.33
|
|
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Week 8 - Exhausted B cells
|
2.83 percentage of cells
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baselineBlood tests of monocytes subsets utilising groups of labelled antibodies
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Baseline - Non-classical monocytes
|
4.88 percentage of cells
Standard Deviation 3.41
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 3 - Non-classical monocytes
|
2.50 percentage of cells
Standard Deviation 1.84
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 4 - Non-classical monocytes
|
2.99 percentage of cells
Standard Deviation 2.01
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 5 - Non-classical monocytes
|
2.94 percentage of cells
Standard Deviation 2.15
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 6 - Non-classical monocytes
|
2.51 percentage of cells
Standard Deviation 2.04
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 7 - Non-classical monocytes
|
2.73 percentage of cells
Standard Deviation 1.80
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 8 - Non-classical monocytes
|
3.26 percentage of cells
Standard Deviation 1.68
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Baseline - Intermediate monocytes
|
7.26 percentage of cells
Standard Deviation 7.17
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 3 - Intermediate monocytes
|
4.00 percentage of cells
Standard Deviation 5.63
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 4 - Intermediate monocytes
|
5.60 percentage of cells
Standard Deviation 5.60
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 5 - Intermediate monocytes
|
5.79 percentage of cells
Standard Deviation 7.20
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 6 - Intermediate monocytes
|
5.41 percentage of cells
Standard Deviation 6.23
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 7 - Intermediate monocytes
|
6.08 percentage of cells
Standard Deviation 6.32
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 8 - Intermediate monocytes
|
7.49 percentage of cells
Standard Deviation 7.31
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Baseline - Classical monocytes
|
78.92 percentage of cells
Standard Deviation 11.78
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 3 - Classical monocytes
|
84.86 percentage of cells
Standard Deviation 8.92
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 4 - Classical monocytes
|
83.27 percentage of cells
Standard Deviation 9.06
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 5 - Classical monocytes
|
83.68 percentage of cells
Standard Deviation 10.25
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 6 - Classical monocytes
|
85.39 percentage of cells
Standard Deviation 8.31
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 7 - Classical monocytes
|
84.87 percentage of cells
Standard Deviation 8.45
|
|
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Week 8 - Classical monocytes
|
82.72 percentage of cells
Standard Deviation 10.86
|
PRIMARY outcome
Timeframe: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baselinePopulation: healthy participants.
Blood tests of NK cell subsets utilising groups of labelled antibodies
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
CD16++CD56- - Baseline
|
0.89 percentage of cells
Standard Deviation 0.62
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 3 - CD16++CD56-
|
0.91 percentage of cells
Standard Deviation 0.50
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 4 - CD16++CD56-
|
0.99 percentage of cells
Standard Deviation 0.44
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 5 - CD16++CD56-
|
0.83 percentage of cells
Standard Deviation 0.39
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 6 - CD16++CD56-
|
1.02 percentage of cells
Standard Deviation 0.58
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 7 - CD16++CD56-
|
1.24 percentage of cells
Standard Deviation 0.60
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 8 - CD16++CD56-
|
1.34 percentage of cells
Standard Deviation 0.56
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Baseline - CD16+CD56+
|
67.89 percentage of cells
Standard Deviation 13.20
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 3 - CD16+CD56+
|
66.63 percentage of cells
Standard Deviation 15.26
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 4 - CD16+CD56+
|
66.31 percentage of cells
Standard Deviation 15.48
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 5 - CD16+CD56+
|
67.07 percentage of cells
Standard Deviation 15.67
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 6 - CD16+CD56+
|
69.92 percentage of cells
Standard Deviation 13.13
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 7 - CD16+CD56+
|
69.86 percentage of cells
Standard Deviation 10.90
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 8 - CD16+CD56+
|
69.04 percentage of cells
Standard Deviation 13.01
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Baseline - CD16+CD56++
|
0.94 percentage of cells
Standard Deviation 0.47
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 3 - CD16+CD56++
|
1.09 percentage of cells
Standard Deviation 0.68
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 4 - CD16+CD56++
|
0.96 percentage of cells
Standard Deviation 0.45
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 5 - CD16+CD56++
|
0.90 percentage of cells
Standard Deviation 0.42
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 6 - CD16+CD56++
|
1.08 percentage of cells
Standard Deviation 0.59
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 7 - CD16+CD56++
|
1.06 percentage of cells
Standard Deviation 0.45
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 8 - CD16+CD56++
|
1.23 percentage of cells
Standard Deviation 0.68
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Baseline - CD16-CD56+
|
2.05 percentage of cells
Standard Deviation 1.01
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 3 - CD16-CD56+
|
1.78 percentage of cells
Standard Deviation 0.98
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 4 - CD16-CD56+
|
1.68 percentage of cells
Standard Deviation 0.69
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 5 - CD16-CD56+
|
1.68 percentage of cells
Standard Deviation 0.84
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 6 - CD16-CD56+
|
1.61 percentage of cells
Standard Deviation 0.73
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 7 - CD16-CD56+
|
1.66 percentage of cells
Standard Deviation 0.73
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 8 - CD16-CD56+
|
1.56 percentage of cells
Standard Deviation 0.84
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Baseline - CD16-CD56++
|
2.98 percentage of cells
Standard Deviation 1.54
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 3 - CD16-CD56++
|
2.90 percentage of cells
Standard Deviation 1.60
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 4 - CD16-CD56++
|
2.66 percentage of cells
Standard Deviation 1.23
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 5 - CD16-CD56++
|
2.61 percentage of cells
Standard Deviation 1.26
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 6 - CD16-CD56++
|
2.84 percentage of cells
Standard Deviation 1.44
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 7 - CD16-CD56++
|
2.67 percentage of cells
Standard Deviation 1.06
|
|
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Week 8 - CD16-CD56++
|
3.16 percentage of cells
Standard Deviation 1.79
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineSodium blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Baseline
|
139.55 mmol/L
Standard Deviation 1.43
|
|
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Week 8
|
139.40 mmol/L
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselinePotassium blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Baseline
|
4.26 mmol/L
Standard Deviation 0.49
|
|
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Week 8
|
4.54 mmol/L
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineUrea blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Baseline
|
4.20 mmol/L
Standard Deviation 1.45
|
|
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Week 8
|
4.04 mmol/L
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineCreatinine blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Baseline
|
69.05 umol/L
Standard Deviation 12.09
|
|
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Week 8
|
68.85 umol/L
Standard Deviation 11.76
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineAST blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
Baseline
|
19.50 U/L
Standard Deviation 3.35
|
|
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
Week 8
|
20.55 U/L
Standard Deviation 4.15
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineALT blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
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|---|---|
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Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
Baseline
|
15.90 U/L
Standard Deviation 7.66
|
|
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
Week 8
|
17.40 U/L
Standard Deviation 9.45
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineAlbumin blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Week 8
|
42.95 g/L
Standard Deviation 2.03
|
|
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Baseline
|
42.80 g/L
Standard Deviation 3.37
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineALP blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
Baseline
|
62.90 U/L
Standard Deviation 19.82
|
|
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
Week 8
|
59.90 U/L
Standard Deviation 15.87
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineBilirubin blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Baseline
|
11.90 umol/L
Standard Deviation 4.09
|
|
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Week 8
|
11.25 umol/L
Standard Deviation 3.50
|
PRIMARY outcome
Timeframe: Baseline and week 8 post-baselineLDH blood tests
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
Baseline
|
310.80 U/L
Standard Deviation 43.87
|
|
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
Week 8
|
377 U/L
Standard Deviation 108.54
|
SECONDARY outcome
Timeframe: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baselineTo analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events
Outcome measures
| Measure |
Reduxium
n=20 Participants
The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days.
|
|---|---|
|
Number of Adverse Events After Reduxium Intake
|
0 adverse events
|
Adverse Events
Reduxium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60