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Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation (TRIPH2017)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907501
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Christine T. Peterson, University of California, San Diego

Brief Summary:
Normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence. Probiotics, such as VSL#3®, and certain herbal supplements such as Triphala are associated with restoration of gut community architecture, increased gut barrier function and decreased inflammation. The present project will examine the potential benefits of a synbiotic (which denotes a prebiotic plus probiotic, and in this study, is an herbal prebiotic plus probiotic) intervention (8 weeks of supplementation) on gut microbiome profiles assessed via stool, inflammatory blood markers, and questionnaires about gastrointestinal health and mood. In this exploratory study, the investigators will examine psychological and physical functioning at baseline and after 8 weeks of supplementation with synbiotic, Triphala alone, or placebo.

Condition or disease Intervention/treatment Phase
Human Microbiome Dietary Supplement: Synbiotic Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Synbiotic
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
Triphala alone

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
Inert capsule




Primary Outcome Measures :
  1. Objective measures of gut microbiome health [ Time Frame: 8 weeks ]
    16S rDNA sequencing of stool sample


Secondary Outcome Measures :
  1. Inflammatory biomarkers [ Time Frame: 8 weeks ]
    Measure concentrations of 30 cytokines in blood samples with standard ELISA panel



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Cognitively intact;
  2. Able to give informed consent in English;
  3. Medical clearance by their doctor;
  4. > 60 years of age.

Exclusion criteria:

  1. Alzheimer's Disease or other neurodegenerative disease such as Parkinson's Disease;
  2. Current use or use in the past 3 months of antimicrobial or steroidal drugs;
  3. Medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV);
  4. Individuals diagnosed with Diabetes Mellitus
  5. International travel in past 3 months.
  6. Previous known side effect or negative reaction to VSL#3 or Triphala

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Christine T Peterson, PhD University of California, San Diego
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Responsible Party: Christine T. Peterson, Assistant Project Scientist, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03907501    
Other Study ID Numbers: TRIPH2017
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine T. Peterson, University of California, San Diego:
Gastrointestinal System
Inflammatory Biomarkers
Psychological Health
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes