A Randomized, Double-blind, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut - a Pilot Study

Vedic Lifesciences Pvt. Ltd.2 sites in 1 country45 target enrollmentAugust 17, 2023

ConditionsGut Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gut Health
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 45
Locations: 2
Primary Endpoint: To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. All the five arms of the IP and placebo trial arms will each have at least 10 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 29 days.

Registry

clinicaltrials.gov

Start Date

August 17, 2023

End Date

May 27, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female individuals with the age ≥18 and ≤65 years with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)
•Body mass index \> 18 and \< 29.9 kg/m2
•Individuals with at least once/ week complains of ≥ 3 of following gastrointestinal symptoms since last three months: dyspepsia, diarrhea, constipation, heartburn, nausea, acid reflux, bloating.
•Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period
•Individuals with fasting blood glucose levels ≤ 125 mg/dL
•Individuals with availability of western toilet at their homes for stool sample collection
•Individuals who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
•Individuals who are able to give written informed consent and are willing to participate in the study.

Exclusion Criteria

•Individuals diagnosed with IBS including IBS-Constipation, IBS-Mixed, IBS-Diarrhea or Unclassified
•Allergy to aspirin
•Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements
•Performing high intensity exercise regularly using IPAQ- SF
•Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening
•Unwillingness to avoid the use of antidiarrheal or laxative medication on a regular or an "as-needed basis" during the full length of the study
•Abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.40 or \> 4.50 μIU/mL
•Individuals with uncontrolled type II DM defined as FBG \> 125 mg/ dL
•Presence of uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg with or without anti-hypertensives
•Individuals on high-fiber/ fodmap diet