NCT05972317 The Stool Microbiome of Treated and Untreated IBS (Irritable Bowel Syndrome) Patients
| NCT ID | NCT05972317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weizmann Institute of Science |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-05-11 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * Male and Female * Age - 18-70 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 the experiment. * Type 1 or type 2 diabetes diagnosis. * Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the 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.
Contact & Investigator
Eran Elinav, Prof
PRINCIPAL INVESTIGATOR
Weizmann Institute of Science
Frequently Asked Questions
Who can join the NCT05972317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05972317 currently recruiting?
Yes, NCT05972317 is actively recruiting participants. Contact the research team at Yotam.cohen@weizmann.ac.il for enrollment information.
Where is the NCT05972317 trial being conducted?
This trial is being conducted at Rehovot, Israel.
Who is sponsoring the NCT05972317 clinical trial?
NCT05972317 is sponsored by Weizmann Institute of Science. The principal investigator is Eran Elinav, Prof at Weizmann Institute of Science. The trial plans to enroll 100 participants.