Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation (TRIPH2017)
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|ClinicalTrials.gov Identifier: NCT03907501|
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2019
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Human Microbiome||Dietary Supplement: Synbiotic Dietary Supplement: Probiotic Dietary Supplement: Placebo||Not Applicable|
Primary Aim: In healthy, cognitively intact elderly subjects, determine the effects of an 8-week synbiotic supplement intervention on the stool microbiome (pre- and post-intervention) as compared to Triphala alone and placebo.
Secondary Aim: In healthy elderly subjects, examine the effects of an 8-week synbiotic supplementation intervention on inflammatory blood markers compared to herb alone or placebo.
Exploratory Aim 1: In healthy elderly subjects, examine the effects of an 8-week synbiotic intervention on gastrointestinal and psychological health via questionnaires compared to herb alone or placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Interested and eligible participants will be randomly assigned to either an 8-week synbiotic group, herb alone, or placebo control with a goal to obtain 60 patients who complete the study (20 in each group) after an estimated 20% attrition. Placebo control subjects will be given the option of having the 8-weeks of herbal synbiotic for directed personal use upon conclusion of the study.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||This study will employ double-blind masking and only the project manager will be aware if the participant is assigned to take the synbiotic, triphala alone, or placebo. At the end of the 8 weeks, participants will be made aware of their randomly assigned supplement.|
|Official Title:||The Effects of Organic Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation in Healthy Elderly Subjects|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||December 31, 2023|
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.
Dietary Supplement: Synbiotic
an herbal prebiotic plus probiotic
Active Comparator: Probiotic
Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.). Subjects will take 2 grams of organic Triphala powder with a few ounces of room temperature water in the morning and at bedtime.
Dietary Supplement: Probiotic
Placebo Comparator: Placebo
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.
Dietary Supplement: Placebo
- Objective measures of gut microbiome health [ Time Frame: 8 weeks ]16S rDNA sequencing of stool sample
- Inflammatory biomarkers [ Time Frame: 8 weeks ]Measure concentrations of 30 cytokines in blood samples with standard ELISA panel
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907501
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Christine T Peterson, PhD||University of California, San Diego|