Weizmann institute of science
Rehovot, Israel
Location status: Recruiting
Location contact
Yotam Cohen
CONTACT
NCT Number: NCT05972317
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Rehovot, Israel
Location status: Recruiting
Yotam Cohen
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intervention will include a guidance by a clinical dietitian about low FODMAP diet
The FODMAP diet has three phases:
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
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
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.
Contact information is provided by the study sponsor or research team.
Weizmann Institute of Science
Other
Generating a Stool Microbiome-based Diagnostic for IBS (Irritable Bowel Syndrome) Patients in Low-FODMAP Treated and Untreated IBS Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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