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

Weizmann Institute of Science

Status: Enrolling

Conditions: Irritable Bowel Syndrome

Treatments: Other: Low FODMAP dietary regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05972317

1914-4

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Non-IBS

No Intervention group

Description:

Participants which are not suffering from IBS symptoms.

IBS -low FODMAP

Experimental group

Description:

individuals that are diagnosed with IBS according to Rome IV criteria

Treatment:

Other: Low FODMAP dietary regimen

FODMAP graduates

No Intervention group

Description:

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