IBS-oriented Crohn's Disease Exclusion Diet versus Low FODMAP Diet for IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two dietary approaches for adults with non-constipated IBS (IBS-D or IBS-M). Participants will follow either a modified Crohn's Disease Exclusion Diet (CDED) or a Low FODMAP diet to see which more effectively reduces IBS symptoms and improves gut health markers. The trial targets adults with moderate-to-severe symptoms and stable IBS medications, excluding those with other GI diseases or conditions that could confound results. Outcomes will include symptom scores and measures related to gut barrier function and microbiota. This is the first attempt to apply an IBS-adapted CDED strategy to understand its potential mechanistic and clinical benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria.
* Moderate-to-severe symptoms (IBS-SSS score ≥175).
* Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics

Exclusion Criteria:

* Coexisting GI diseases \[e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease \[positive transglutaminase (TTG) serology\].
* Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease \[abnormal Thyroid-Stimulating Hormone (TSH)\], and bariatric surgery.
* Recent intestinal resection.
* Pregnancy or breastfeeding.
* Known food allergies.
* Current active eating disorder
* Participants already following a restrictive diet, including diets that overlap with the interventions in this study, will be excluded to prevent confounding effects on gut microbiota composition and gastrointestinal symptoms, and to ensure consistent baseline conditions. However, individuals who have discontinued such diets at least two to four weeks prior to enrollment may be eligible, allowing for a sufficient dietary washout period to minimize residual effects on the gut microbiota.
* Currently under obesity management medication treatment.
* Vegans
* Use of antibiotics within the 4 weeks prior to enrollment or during the study period.
* Abnormal hemoglobin levels (for women\<11.5 gr/dl, for men\<13 gr/dl)29
* Baseline CRP≥5

Where it's running

• Sheba Medical Center, Tel Hashomer
  Ramat Gan, Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Keren Hod, RD PhD
• Email: kerenho@ariel.ac.il
• Phone: +972-53-2214380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.