The Stool Microbiome of Treated and Untreated IBS (Irritable Bowel Syndrome) Patients

Last updated: July 16, 2025
Sponsor: Weizmann Institute of Science
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lactose Intolerance

Colic

Gastrointestinal Diseases And Disorders

Treatment

Low FODMAP dietary regimen

Clinical Study ID

NCT05972317
1914-4
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. The two main mechanisms invoking IBS development and flares include 1) an increase in luminal water content due to malabsorption of small molecules and 2) incrementation of colon gas production generated by the fermentation of small molecules by gut bacteria.Yet to date, a person-specific elucidation of the specific small molecules and bacteria driving IBS, and their downstream effects on the human gut epithelium remain unknown.

Over the past years, it became evident that dietary regimes, and their interactions with the intestinal microbiome, are at the center of IBS symptom generation and alleviation. The most widely used dietary intervention is a highly restrictive diet, the low-Fermentable Oligo-saccharides Di-saccharides Mono-saccharides And Polyols (FODMAP) diet, based on avoidance of multiple food items that contain available fermentable molecules.

The low-FODMAP diet remains an effective line of treatment for IBS patients, yet due to its complexity and unhealthy nature, it remains a last line of treatment and fails to impact the majority of IBS patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and Female

  • Age - 18-70

Exclusion

Exclusion Criteria:

  • Consumption of antibiotics 2 months prior to the first day of the experiment.

  • Consumption of probiotic supplements 1 month prior to the first day of theexperiment.

  • Type 1 or type 2 diabetes diagnosis.

  • Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day ofthe study.

  • Chronic disease - to the discretion of the study doctor.

  • Cancer and recent anticancer treatment.

  • Psychiatric disorders - to the discretion of the study doctor.

  • IBD (inflammatory bowel diseases).

  • Alcohol or substance abuse.

  • BMI > 35.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Low FODMAP dietary regimen
Phase:
Study Start date:
April 10, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Weizmann institute of science

    Rehovot,
    Israel

    Active - Recruiting

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