Trial Outcomes & Findings for Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation (NCT NCT03907501)
NCT ID: NCT03907501
Last Updated: 2023-07-06
Results Overview
16S rDNA sequencing of stool sample
TERMINATED
NA
75 participants
8 weeks
2023-07-06
Participant Flow
Recruitment dates 07/01/2019 - 11/01/2019. The location is UCSD School of Medicine Building 4 via IRB approved phone script. 34 subjects were approved for enrollment for our first wave of intervention/subjects and 18 began the study before the study was closed.
18 subjects began the intervention (2 dropped out) before the study was closed. Few subjects were able to begin the intervention compared to what was planned before the study was closed due to multiple pandemic related impacts. As the budget was impacted, no data was generated. No data is reported as the samples will not be processed and no data was generated.
Participant milestones
| Measure |
Synbiotic
Synbiotic Group. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules. Subjects will take 2 grams of encapsulated organic Triphala powder and 1 capsule of VSL#3 with room temperature water in the morning and at bedtime.
Synbiotic: an herbal prebiotic plus probiotic
|
Triphala
Triphala Group. Subjects will be provided both written and verbal instructions and given a kit containing Triphala capsules (Banyan Botanicals). Subjects will take 4 capsules (2g) of Triphala with room temperature water in the morning and at bedtime.
Triphala: encapsulated
|
Placebo
Subjects will be provided both written and verbal instructions and given a kit containing encapsulated placebo powder (made by VSL#3 manufacterer). Subjects will take 2 grams of organic placebo powder with a few ounces of room temperature water in the morning and at bedtime.
Placebo: Inert capsule
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Synbiotic
n=7 Participants
Two grams of organic Triphala powder (Banyan Botanicals, Inc.) with 1 capsule VSL#3® (VSL Pharmaceuticals, Inc.) probiotic taken with a few ounces of room temperature water in the morning and at bedtime for 8 weeks. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules.
Synbiotic: an herbal prebiotic plus probiotic
|
Triphala
n=6 Participants
Triphala Group. Subjects will be provided both written and verbal instructions and given a kit containing Triphala capsules (Banyan Botanicals). Subjects will take 4 capsules (2g) of Triphala with room temperature water in the morning and at bedtime.
Triphala: encapsulated
|
Placebo
n=5 Participants
Subjects will be provided both written and verbal instructions and given a kit containing placebo capsules. Subjects will be instructed to take 2 (inert) capsules with room temperature water in the morning and at bedtime.
Placebo: Inert capsule
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=18 Participants
|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
74.5 years
STANDARD_DEVIATION 8.4 • n=6 Participants
|
73.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
72.2 years
STANDARD_DEVIATION 6.7 • n=18 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Study closed due to COVID-19. No data was generated. No data was analyzed.
16S rDNA sequencing of stool sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: No data was generated or analyzed. Study closed due to COVID-19 impacts.
Measure concentrations of 30 cytokines in blood samples with standard ELISA panel
Outcome measures
Outcome data not reported
Adverse Events
Synbiotic
Probiotic
Placebo
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