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

Overview

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.

Interventions

• Other Low FODMAP dietary regimen
  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.

Primary outcome measures

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

Secondary outcome measures (1)

• Stool microbiome differences between the study arms - using fecal samples of participants [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Israel · 1 center

• Weizmann institute of science — Rehovot

Identifiers

NCT: NCT05972317 · 3328-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗