NCT07707635Not yet recruiting
IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population. Objectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability. Methods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150. Following a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries \[Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)\], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point. Stool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes. Significance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 5 Jul 2026
- Start date
- 7 Jul 2026
- Primary completion date
- 30 Jul 2028
- Lead sponsor
- Ariel University
- Diseases
- Crohn's disease
- NCT number
- NCT07707635
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 7 Jul 2026 to the primary completion date, 30 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent intestinal resection.
- 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.
- Use of antibiotics within the 4 weeks prior to enrollment or during the study period.
Other illness
- 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.
- Known food allergies.
- Current active eating disorder
Lab values
- Abnormal hemoglobin levels (for women\<11.5 gr/dl, for men\<13 gr/dl)29
Other
- Pregnancy or breastfeeding.
- Vegans
- Baseline CRP≥5
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.