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

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ClinicalTrials.gov Identifier: NCT05972317
Recruitment Status : Not yet recruiting
First Posted : August 2, 2023
Last Update Posted : August 2, 2023
Sponsor:
Information provided by (Responsible Party):
Weizmann Institute of Science

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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:

  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.
No Intervention: FODMAP graduates
Individuals who have practiced a low-FODMAP diet in the past


Outcome Measures
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Primary Outcome Measures :
  1. IBS-SSS - irritable bowel syndrome severity score system questionnaire [ Time Frame: 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

  2. IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire [ Time Frame: 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 :
  1. Stool microbiome differences between the study arms - using fecal samples of participants [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05972317


Contacts
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Contact: Yotam Cohen +97289529173 Yotam.cohen@weizmann.ac.il
Contact: Shimrit Eliyahu Miller shimrit.miller@weizmann.ac.il

Sponsors and Collaborators
Weizmann Institute of Science
Investigators
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Principal Investigator: Eran Elinav, Prof Weizmann Institute of Science
More Information
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Responsible Party: Weizmann Institute of Science
ClinicalTrials.gov Identifier: NCT05972317    
Other Study ID Numbers: 1914-4
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: August 2, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases