Clinical trial NCT05972317: The Stool Microbiome of Treated and Untreated IBS (Irritable Bowel Syndrome) Patients
Official title: Generating a Stool Microbiome-based Diagnostic for IBS (Irritable Bowel Syndrome) Patients in Low-FODMAP Treated and Untreated IBS Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Weizmann Institute of Science
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Primary outcomes:
measure: IBS-SSS - irritable bowel syndrome severity score system questionnaire
timeFrame: 1 week
measure: IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: Stool microbiome differences between the study arms - using fecal samples of participants
timeFrame: 3 months
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Weizmann institute of science
Study officials:
affiliation: Weizmann Institute of Science
name: Eran Elinav, Prof
role: PRINCIPAL_INVESTIGATOR
References: