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

Sponsor

Weizmann Institute of Science (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972317

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Other: Low FODMAP dietary regimen	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Generating a Stool Microbiome-based Diagnostic for IBS (Irritable Bowel Syndrome) Patients in Low-FODMAP Treated and Untreated IBS Patients

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Non-IBS Participants which are not suffering from IBS symptoms.
Experimental: IBS -low FODMAP individuals that are diagnosed with IBS according to Rome IV criteria	Other: Low FODMAP dietary regimen intervention will include a guidance by a clinical dietitian about low FODMAP diet The FODMAP diet has three phases: Elimination - Avoidance from high-FODMAP foods (2-6 weeks) Reintroduction -Structured challenges of specific food groups each time (6-8 weeks). Maintenance - personalized diet, according to the response in step 2.
No Intervention: FODMAP graduates Individuals who have practiced a low-FODMAP diet in the past

Arm

Intervention/Treatment

No Intervention: Non-IBS

Participants which are not suffering from IBS symptoms.

Experimental: IBS -low FODMAP

individuals that are diagnosed with IBS according to Rome IV criteria

Other: Low FODMAP dietary regimen

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

No Intervention: FODMAP graduates

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

Outcome Measures

Primary Outcome Measures

IBS-SSS - irritable bowel syndrome severity score system questionnaire [1 week]
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
IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire [1 week]
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

Secondary Outcome Measures

Stool microbiome differences between the study arms - using fecal samples of participants [3 months]
Analysis of stool samples of the different study arms - using shot-gun metagenomics to asses type of microbiota pre and post low-FODMAP diet.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Weizmann Institute of Science

Investigators

Principal Investigator: Eran Elinav, Prof, Weizmann Institute of Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weizmann Institute of Science

ClinicalTrials.gov Identifier:

NCT05972317

Other Study ID Numbers:

1914-4

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Study Results

No Results Posted as of Aug 2, 2023