Cure8 trial brief
Why This Matters
This registered trial tests whether an adapted Crohn’s Disease Exclusion Diet can match or outperform the low‑FODMAP diet for non‑constipated IBS while targeting low‑grade inflammation, gut barrier function, and microbiota — mechanisms relevant to some IBS cases.
Who Should Pay Attention
Adults with IBS‑D or IBS‑M; gastroenterologists and dietitians; researchers in gut microbiome, inflammation, and dietary therapies.
Study Snapshot
What To Know
This is a randomized, single‑center, open‑label study planning to enroll 150 adults with Rome IV‑defined non‑constipated IBS and moderate‑to‑severe symptoms. Participants are assigned 1:1 to a modified CDED (without enteral formula) or standard low‑FODMAP diet for 6 weeks with dietary counseling.
Clinical symptom scores, stool diaries, validated questionnaires, fecal inflammatory and permeability markers, and 16S rRNA microbiota profiling will be collected at baseline, week 3, and week 6.
The study’s main goal is to test whether the modified CDED is at least as effective as the low‑FODMAP diet for symptom relief, and whether it has superior effects on low‑grade inflammation, barrier function, and microbiota composition. Results are not yet available; the registry lists the study as not yet recruiting.
Keep In Mind
Registry record (not yet recruiting) describes planned methods and outcomes but provides no results. The CDED here is modified for IBS and omits the enteral formula used in Crohn’s disease protocols.
Source Details
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.