IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome
Not applicable · Testing Modified Crohn's Disease Exclusion Diet (CDED) and Low FODMAP Diet · Sites not listed yet · Ariel University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Modified Crohn's Disease Exclusion Diet (CDED) and Low FODMAP Diet as a possible treatment. Condition(s) listed: Irritable Bowel Syndrome (IBS).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2026-07-07 (planned).
- Main results expected around 2028-07-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS]) (Baseline and Week 6)
In the researchers’ words
Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Irritable Bowel Syndrome (IBS) |
| Lead sponsor | Ariel University |
| Collaborators | Sheba Medical Center; Ministry of Innovation, Science and Technology of Israel |
| Enrollment | 150 (estimated) |
| Start date | 2026-07-07 |
| Primary completion (est.) | 2028-07-30 |
| First posted | 2026-07-16 |
| Last updated | 2026-07-16 |
| Official title | Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome |
| ClinicalTrials.gov ID | NCT07707635 |
Interventions
- Modified Crohn's Disease Exclusion Diet (CDED) (Other)
Participants will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling. - Low FODMAP Diet (Other)
Participants will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling.
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.