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

Human Microbiome Clinical Trial

— TRIPH2017  

Official title:

The Effects of Organic Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation in Healthy Elderly Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03907501
• Other study ID #: TRIPH2017
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 12, 2021

Study information

• Verified date: July 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: July 12, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Microbiome
• Inflammation

Intervention

Dietary Supplement:
• Synbiotic
an herbal prebiotic plus probiotic
• Probiotic
Triphala alone
• Placebo
Inert capsule

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Measures of Gut Microbiome Health	16S rDNA sequencing of stool sample	8 weeks
Secondary	Inflammatory Biomarkers	Measure concentrations of 30 cytokines in blood samples with standard ELISA panel	8 weeks