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

NCT05972317 | Recruiting

• 1 other identifier: 1914-4
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• IBS-SSS - irritable bowel syndrome severity score system questionnaire

  Severity of symptoms as they are scored in the Rome IV IBS-SSS 75 to \<175 to indicate mild IBS, 175 to \<300 as moderate, and \>300 as severe

  1 week

• IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire

  Quality of life scores from the Rome IV IBS-QOL 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life

  1 week

Secondary Outcomes (1)

• Stool microbiome differences between the study arms - using fecal samples of participants

  3 months

Study Arms (3)

Non-IBS

NO INTERVENTION

Participants which are not suffering from IBS symptoms.

IBS -low FODMAP

EXPERIMENTAL

individuals that are diagnosed with IBS according to Rome IV criteria

Other: Low FODMAP dietary regimen

FODMAP graduates

NO INTERVENTION

Individuals who have practiced a low-FODMAP diet in the past

Interventions

Low FODMAP dietary regimen OTHER

intervention will include a guidance by a clinical dietitian about low FODMAP diet The FODMAP diet has three phases: 1. Elimination - Avoidance from high-FODMAP foods (2-6 weeks) 2. Reintroduction -Structured challenges of specific food groups each time (6-8 weeks). 3. Maintenance - personalized diet, according to the response in step 2.

IBS -low FODMAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female
• Age - 18-70

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weizmann Institute of Science: lead

Study Sites (1)

Weizmann institute of science

Rehovot, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Eran Elinav, Prof

  Weizmann Institute of Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yotam Cohen

CONTACT

+97289529173; Yotam.cohen@weizmann.ac.il

Shimrit Eliyahu Miller

CONTACT

shimrit.miller@weizmann.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: August 2, 2023
• Study Start: April 10, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-02

Locations

IL (1)