Trial Outcomes & Findings for Dietary Supplement With and Without a Probiotic (NCT NCT04433208)
NCT ID: NCT04433208
Last Updated: 2025-03-18
Results Overview
qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
|
Cohort 2 (Complex Oligosaccharide)
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
9
|
10
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1 (Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
|
Cohort 2 (Complex Oligosaccharide)
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dietary Supplement With and Without a Probiotic
Baseline characteristics by cohort
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
|
Cohort 2 (Complex Oligosaccharide)
n=10 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
n=12 Participants
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
62 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 7 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
31.1 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
34.6 years
STANDARD_DEVIATION 5.8 • n=8 Participants
|
33.5 years
STANDARD_DEVIATION 6.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
12 participants
n=21 Participants
|
10 participants
n=8 Participants
|
62 participants
n=8 Participants
|
|
Hemoglobin
|
14.2 g/dL
STANDARD_DEVIATION 2.45 • n=5 Participants
|
14.3 g/dL
STANDARD_DEVIATION 1.88 • n=7 Participants
|
13.7 g/dL
STANDARD_DEVIATION 1.51 • n=5 Participants
|
14.2 g/dL
STANDARD_DEVIATION 1.62 • n=4 Participants
|
14.8 g/dL
STANDARD_DEVIATION 1.40 • n=21 Participants
|
14.6 g/dL
STANDARD_DEVIATION 1.31 • n=8 Participants
|
14.3 g/dL
STANDARD_DEVIATION 1.69 • n=8 Participants
|
PRIMARY outcome
Timeframe: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57Population: Changes in microbiome species abundance and diversity
qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.
Outcome measures
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic: Probiotic
|
Cohort 2 (Complex Oligosaccharide)
n=9 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
n=10 Participants
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
PPI: Over-the-counter proton pump inhibitor (PPI)
H2 Blocker: Over-the-counter H2 blocker
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
n=9 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 1
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 5
|
322.38 copies/ng DNA
Interval 180.53 to 575.66
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
127.48 copies/ng DNA
Interval 25.63 to 634.11
|
64.03 copies/ng DNA
Interval 11.95 to 343.12
|
263.20 copies/ng DNA
Interval 63.06 to 1098.58
|
371.37 copies/ng DNA
Interval 38.92 to 3543.55
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 8
|
276.67 copies/ng DNA
Interval 120.16 to 637.05
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
271.21 copies/ng DNA
Interval 70.59 to 1042.03
|
180.24 copies/ng DNA
Interval 65.35 to 497.154
|
391.72 copies/ng DNA
Interval 23.31 to 6581.7
|
1454.29 copies/ng DNA
Interval 103.68 to 20398.61
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 15
|
5.36 copies/ng DNA
Interval 1.83 to 15.67
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
21.83 copies/ng DNA
Interval 2.78 to 171.51
|
18.89 copies/ng DNA
Interval 1.87 to 190.47
|
111.46 copies/ng DNA
Interval 4.98 to 2494.13
|
1636.68 copies/ng DNA
Interval 64.35 to 41626.43
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 22
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
9.13 copies/ng DNA
Interval 2.16 to 38.63
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 29
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 33
|
—
|
—
|
—
|
—
|
59.74 copies/ng DNA
Interval 9.24 to 386.15
|
—
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 36
|
—
|
—
|
—
|
—
|
72.34 copies/ng DNA
Interval 8.26 to 633.77
|
—
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 43
|
—
|
—
|
—
|
—
|
22.96 copies/ng DNA
Interval 1.25 to 421.63
|
—
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 50
|
—
|
—
|
—
|
—
|
4.07 copies/ng DNA
Interval 2.59 to 6.41
|
—
|
|
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Day 57
|
—
|
—
|
—
|
—
|
3.33 copies/ng DNA
Interval 3.33 to 3.33
|
—
|
SECONDARY outcome
Timeframe: Day 1 - 15Population: Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantification. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Measurements were only taken for Cohorts 1, 2 and 6.
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Outcome measures
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic: Probiotic
|
Cohort 2 (Complex Oligosaccharide)
n=10 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=9 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
PPI: Over-the-counter proton pump inhibitor (PPI)
H2 Blocker: Over-the-counter H2 blocker
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Brain-Derived Neurotrophic Factor (BDNF) - Study Day 1
|
14.10 pg/mL
Standard Deviation 5.38
|
17.36 pg/mL
Standard Deviation 5.92
|
16.30 pg/mL
Standard Deviation 4.51
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Brain-Derived Neurotrophic Factor (BDNF) - Study Day 15
|
13.43 pg/mL
Standard Deviation 6.06
|
16.82 pg/mL
Standard Deviation 4.34
|
16.00 pg/mL
Standard Deviation 3.94
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Eotaxin-2 - Study Day 1
|
928.70 pg/mL
Standard Deviation 261.85
|
1129.50 pg/mL
Standard Deviation 247.49
|
1004.89 pg/mL
Standard Deviation 362.32
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Eotaxin-2 - Study Day 15
|
931.80 pg/mL
Standard Deviation 289.66
|
1214.00 pg/mL
Standard Deviation 304.64
|
1112.78 pg/mL
Standard Deviation 437.58
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-1 beta (IL-1 beta) - Study Day 1
|
10.90 pg/mL
Standard Deviation 2.32
|
9.90 pg/mL
Standard Deviation 4.22
|
9.28 pg/mL
Standard Deviation 4.12
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-1 beta (IL-1 beta) - Study Day 15
|
9.75 pg/mL
Standard Deviation 3.91
|
10.50 pg/mL
Standard Deviation 4.46
|
10.68 pg/mL
Standard Deviation 2.07
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-1 receptor antagonist (IL-1ra) - Study Day 1
|
108.80 pg/mL
Standard Deviation 30.44
|
118.90 pg/mL
Standard Deviation 27.52
|
108.33 pg/mL
Standard Deviation 26.83
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-1 receptor antagonist (IL-1ra) - Study Day 15
|
118.90 pg/mL
Standard Deviation 17.76
|
111.22 pg/mL
Standard Deviation 36.89
|
104.00 pg/mL
Standard Deviation 25.09
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-12 Subunit p40 (IL-12p40) - Study Day 1
|
0.66 pg/mL
Standard Deviation 0.17
|
0.60 pg/mL
Standard Deviation 0.17
|
0.65 pg/mL
Standard Deviation 0.08
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-12 Subunit p40 (IL-12p40) - Study Day 15
|
0.69 pg/mL
Standard Deviation 0.14
|
0.60 pg/mL
Standard Deviation 0.22
|
0.67 pg/mL
Standard Deviation 0.17
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-18 (IL-18) - Study Day 1
|
207.10 pg/mL
Standard Deviation 124.68
|
208.00 pg/mL
Standard Deviation 77.16
|
187.33 pg/mL
Standard Deviation 79.43
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Interleukin-18 (IL-18) - Study Day 15
|
187.20 pg/mL
Standard Deviation 100.18
|
223.22 pg/mL
Standard Deviation 92.55
|
180.00 pg/mL
Standard Deviation 85.23
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 1
|
35.20 pg/mL
Standard Deviation 6.00
|
33.90 pg/mL
Standard Deviation 4.91
|
30.67 pg/mL
Standard Deviation 10.46
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 15
|
34.70 pg/mL
Standard Deviation 7.41
|
35.33 pg/mL
Standard Deviation 5.89
|
32.11 pg/mL
Standard Deviation 8.54
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 1
|
427.80 pg/mL
Standard Deviation 184.10
|
390.30 pg/mL
Standard Deviation 275.65
|
329.22 pg/mL
Standard Deviation 161.56
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 15
|
430.60 pg/mL
Standard Deviation 222.27
|
408.11 pg/mL
Standard Deviation 295.14
|
335.44 pg/mL
Standard Deviation 148.03
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Vascular Endothelial Growth Factor (VEGF) - Study Day 1
|
288.70 pg/mL
Standard Deviation 112.99
|
233.60 pg/mL
Standard Deviation 79.24
|
200.11 pg/mL
Standard Deviation 95.08
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Vascular Endothelial Growth Factor (VEGF) - Study Day 15
|
303.70 pg/mL
Standard Deviation 125.31
|
252.78 pg/mL
Standard Deviation 117.20
|
198.22 pg/mL
Standard Deviation 89.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57Population: Microbiome Population (Two cohorts received 18g of HMO with B. infantis and will be distinguished from each other by one receiving the proton pump inhibitor omeprazole. In addition, the cohort dosed with omeprazole received a second round of dosing with half of the subjects receiving famotidine in addition to B. infantis and 18g of HMO and the remainder not receiving any acid reducing drugs)
Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA).
Outcome measures
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic: Probiotic
|
Cohort 2 (Complex Oligosaccharide)
n=9 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
PPI: Over-the-counter proton pump inhibitor (PPI)
H2 Blocker: Over-the-counter H2 blocker
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 1
|
3.3 B. infantis (copies/ng DNA)
Interval 3.3 to 3.3
|
3.3 B. infantis (copies/ng DNA)
Interval 3.3 to 3.3
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 5
|
263.2 B. infantis (copies/ng DNA)
Interval 63.1 to 1098.6
|
371.4 B. infantis (copies/ng DNA)
Interval 38.9 to 3543.5
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 8
|
391.7 B. infantis (copies/ng DNA)
Interval 23.3 to 6581.7
|
1454.3 B. infantis (copies/ng DNA)
Interval 103.7 to 20398.6
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 15
|
111.5 B. infantis (copies/ng DNA)
Interval 5.0 to 2494.1
|
1636.7 B. infantis (copies/ng DNA)
Interval 64.4 to 41626.4
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 22
|
3.3 B. infantis (copies/ng DNA)
Interval 3.3 to 3.3
|
9.1 B. infantis (copies/ng DNA)
Interval 2.2 to 38.6
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 29
|
3.3 B. infantis (copies/ng DNA)
Interval 3.3 to 3.3
|
3.3 B. infantis (copies/ng DNA)
Interval 3.3 to 3.3
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 33
|
59.7 B. infantis (copies/ng DNA)
Interval 9.2 to 386.2
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 36
|
72.3 B. infantis (copies/ng DNA)
Interval 8.3 to 633.8
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 43
|
23.0 B. infantis (copies/ng DNA)
Interval 1.3 to 421.6
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 50
|
4.1 B. infantis (copies/ng DNA)
Interval 2.6 to 6.4
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Day 57
|
3.3 B. infantis (copies/ng DNA)
Interval 3.3 to 3.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, 8, 15, 29Population: Cohort 1 (no HMO, only B. infantis), Cohort 2 (18g HMO, no B. infantis). Cohorts 5 and 6 were combined because both of these groups received 18g HMO +B. infantis and this was pre-specified in the analysis plan for this outcome. The measurement of lactic acid was expected, therefore, to be very similar between these two groups and the goal of this analysis was to compare the combination of a probiotic with complex oligosaccharides to each of these separately (Cohorts 1 and 2, respectively).
Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 \& 6 combined; 18g HMO + B. infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples.
Outcome measures
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic: Probiotic
|
Cohort 2 (Complex Oligosaccharide)
n=9 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=11 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
n=8 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
PPI: Over-the-counter proton pump inhibitor (PPI)
H2 Blocker: Over-the-counter H2 blocker
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Lactic acid - Day 1
|
0.11 µmol/g
Standard Deviation 0.04
|
0.39 µmol/g
Standard Deviation 0.74
|
3.18 µmol/g
Standard Deviation 10.02
|
0.14 µmol/g
Standard Deviation 0.05
|
—
|
—
|
|
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Lactic acid - Day 8
|
0.18 µmol/g
Standard Deviation 0.14
|
0.20 µmol/g
Standard Deviation 0.20
|
0.17 µmol/g
Standard Deviation 0.05
|
0.16 µmol/g
Standard Deviation 0.08
|
—
|
—
|
|
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Lactic acid - Day 15
|
0.13 µmol/g
Standard Deviation 0.11
|
0.14 µmol/g
Standard Deviation 0.06
|
0.85 µmol/g
Standard Deviation 1.14
|
0.12 µmol/g
Standard Deviation 0.06
|
—
|
—
|
|
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Lactic acid - Day 29
|
0.18 µmol/g
Standard Deviation 0.14
|
0.13 µmol/g
Standard Deviation 0.05
|
0.40 µmol/g
Standard Deviation 0.93
|
0.12 µmol/g
Standard Deviation 0.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 - 15Population: Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantitation. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Data were only available for Cohorts 1, 2 and 6.
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Outcome measures
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic: Probiotic
|
Cohort 2 (Complex Oligosaccharide)
n=10 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=9 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
PPI: Over-the-counter proton pump inhibitor (PPI)
H2 Blocker: Over-the-counter H2 blocker
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)
Factor VII - Day 1
|
354.0 ug/mL
Standard Deviation 104.0
|
382.9 ug/mL
Standard Deviation 90.0
|
362.3 ug/mL
Standard Deviation 76.0
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)
Factor VII - Day 15
|
358.5 ug/mL
Standard Deviation 124.7
|
403.6 ug/mL
Standard Deviation 99.6
|
384.2 ug/mL
Standard Deviation 79.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 - 15Population: Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantification. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Data were only available for Cohorts 1, 2 and 6.
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose.
Outcome measures
| Measure |
Cohort 1 (Probiotic)
n=10 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic: Probiotic
|
Cohort 2 (Complex Oligosaccharide)
n=10 Participants
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=9 Participants
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide: Complex oligosaccharide concentrate
Probiotic: Probiotic
PPI: Over-the-counter proton pump inhibitor (PPI)
H2 Blocker: Over-the-counter H2 blocker
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)
Intercellular Adhesion Molecule 1 (ICAM-1) - Day 1
|
71.0 ng/mL
Standard Deviation 18.4
|
68.6 ng/mL
Standard Deviation 23.5
|
65.1 ng/mL
Standard Deviation 21.8
|
—
|
—
|
—
|
|
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)
Intercellular Adhesion Molecule 1 (ICAM-1) - Day 15
|
65.2 ng/mL
Standard Deviation 16.2
|
75.1 ng/mL
Standard Deviation 28.6
|
73.0 ng/mL
Standard Deviation 27.5
|
—
|
—
|
—
|
Adverse Events
Cohort 1 (Probiotic)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 (Complex Oligosaccharide)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 (Probiotic)
n=10 participants at risk
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
|
Cohort 2 (Complex Oligosaccharide)
n=10 participants at risk
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
|
Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic)
n=10 participants at risk
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
|
Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic)
n=10 participants at risk
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
|
Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker)
n=12 participants at risk
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
|
Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic)
n=10 participants at risk
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bacteria Vaginosis
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
8.3%
1/12 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
8.3%
1/12 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
General disorders
Decreased appetite
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Nervous system disorders
Cubital Tunnel Syndrome
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
10.0%
1/10 • Number of events 1 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/12 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
0.00%
0/10 • Cohort 1,2,3,4,6 - 38 days Cohort 5 - 73 days
|
Additional Information
Dr David Rechtman VP, Medical Affairs
Prolacta Bioscience
Phone: 8887765228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place