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

Primary Purpose

Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low FODMAP dietary regimen
Sponsored by
Weizmann Institute of Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    No Intervention

    Arm Label

    Non-IBS

    IBS -low FODMAP

    FODMAP graduates

    Arm Description

    Participants which are not suffering from IBS symptoms.

    individuals that are diagnosed with IBS according to Rome IV criteria

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

    Outcomes

    Primary Outcome Measures

    IBS-SSS - irritable bowel syndrome severity score system questionnaire
    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
    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
    Analysis of stool samples of the different study arms - using shot-gun metagenomics to asses type of microbiota pre and post low-FODMAP diet.

    Full Information

    First Posted
    March 2, 2023
    Last Updated
    July 23, 2023
    Sponsor
    Weizmann Institute of Science
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05972317
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Weizmann Institute of Science

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-IBS
    Arm Type
    No Intervention
    Arm Description
    Participants which are not suffering from IBS symptoms.
    Arm Title
    IBS -low FODMAP
    Arm Type
    Experimental
    Arm Description
    individuals that are diagnosed with IBS according to Rome IV criteria
    Arm Title
    FODMAP graduates
    Arm Type
    No Intervention
    Arm Description
    Individuals who have practiced a low-FODMAP diet in the past
    Intervention Type
    Other
    Intervention Name(s)
    Low FODMAP dietary regimen
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    IBS-SSS - irritable bowel syndrome severity score system questionnaire
    Description
    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
    Time Frame
    1 week
    Title
    IBS-QOL questionnaire - irritable bowel syndrome quality of life questionnaire
    Description
    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
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Stool microbiome differences between the study arms - using fecal samples of participants
    Description
    Analysis of stool samples of the different study arms - using shot-gun metagenomics to asses type of microbiota pre and post low-FODMAP diet.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yotam Cohen
    Phone
    +97289529173
    Email
    Yotam.cohen@weizmann.ac.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shimrit Eliyahu Miller
    Email
    shimrit.miller@weizmann.ac.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eran Elinav, Prof
    Organizational Affiliation
    Weizmann Institute of Science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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