Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT05972317

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

Led by Weizmann Institute of Science · Updated on 2025-07-20

200

Participants Needed

1

Research Sites

133 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and Female
  • Age between 18 and 70 years
Not Eligible

You will not qualify if you...

  • Use of antibiotics within 2 months before the study
  • Use of probiotic supplements within 1 month before the study
  • Diagnosis of type 1 or type 2 diabetes
  • Pregnancy, breastfeeding, or fertility treatments within 3 months before the study
  • Presence of chronic diseases as determined by the study doctor
  • History of cancer or recent anticancer treatment
  • Psychiatric disorders as determined by the study doctor
  • Diagnosis of inflammatory bowel diseases (IBD)
  • Alcohol or substance abuse
  • Body mass index (BMI) greater than 35

AI-Screening

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Trial Site Locations

Total: 1 location

1

Weizmann institute of science

Rehovot, Israel, Israel

Actively Recruiting

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Research Team

Y

Yotam Cohen

CONTACT

S

Shimrit Eliyahu Miller

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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