A Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut.

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

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.

Study Overview

• Status: Completed
• Conditions: Gut Health
• Intervention / Treatment: Dietary supplement: PA-GH-01; Dietary supplement: MK-GH-04; Dietary supplement: TSH-GH-03; Dietary supplement: PA-GH-02

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400053
      • Dr. Kumta Mali's Clinic
    • Thāne, Maharashtra, India, 400607
      • Dr. Preeti Bawaskar's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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
• Individuals with known diagnosis of helicobacter pylori infection
• Individuals with a history of surgical resection of the stomach, small intestine or large intestine
• Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis
• Current smokers
• Use of another investigational product within 3 months of the screening visit
• History or current impaired cardiovascular circulation or uncontrolled hypertension, diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseases including asthma, or any other disease, that by the investigators' discretion could interfere with the intestinal barrier function of the subject
• Individuals who used probiotics, prebiotics, antibiotics, prokinetics, laxatives, suppositories or enemas in the last 3 months
• Individuals with a history of any diet-based intolerance (gluten or lactose intolerance)
• Individuals with a history of or complications from malignant tumors.
• History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
• Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
• High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men
• Individuals who have clinically significant following illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, other gastrointestinal diseases, etc
• Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives
• Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PA-GH-01; 1 capsule after breakfast once a day	Dietary supplement: PA-GH-01; 1 capsule after breakfast once a day
Active Comparator: MK-GH-04; 1 capsule after breakfast once a day	Dietary supplement: MK-GH-04; 1 capsule after breakfast once a day
Active Comparator: TSH-GH-03; 1 capsule after breakfast once a day	Dietary supplement: TSH-GH-03; 1 capsule after breakfast once a day
Placebo Comparator: PA-GH-02; 1 capsule after breakfast once a day	Dietary supplement: PA-GH-02; 1 capsule after breakfast once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Gut permeability as assessed by the urinary lactulose-mannitol ratio from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Gut protection as assessed by the Aspirin challenge test from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Stool consistency as assessed by Bristol Stool Type from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Gut microbiome as assessed by the fecal pH from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Quality of life as assessed by gastrointestinal quality of life index (GIQLI) from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	The stress level as assessed by change in the Perceived Stress Scale (PSS) from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Appetite regulation as assessed by a Three-Factor Eating Questionnaire-R18 (TFEQ-R18) from baseline	Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in	Motivation to exercise as assessed by VAS score from baseline	Day 29

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EB/230301/TPEKC/LG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No