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Recruiting
NCT05972317
IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial
Conditions: Irritable Bowel Syndrome
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Weizmann Institute of Science
Location: Weizmann institute of science Rehovot
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. This placebo-controlled interventional study examines person-specific small molecules and bacteria driving IBS and their downstream effects on the human gut epithelium.
Eligibility Criteria
Inclusion Criteria:
* Male and Female
* Age - 18-70
Exclusion Criteria:
* Consumption of antibiotics 2 months prior to enrolment.
* Consumption of probiotic supplements 2 weeks prior to enrolment.
* 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 medical team.
* Cancer and recent anticancer treatment.
* Immunosuppression.
* Psychiatric disorders - to the discretion of the medical team
* History of gastrointestinal surgeries - to the discretion of the medical team
* Inflammatory bowel diseases or gastrointestinal disorders - to the discretion of the medical team
* Unstable doses of medications in the past 2 months
* Alcohol or substance abuse.
Source: ClinicalTrials.gov (NCT05972317). StuddyBuddy aggregates publicly available trial information.