Malaysian-adapted Asian Crohn's disease diet
Official title: Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome
Run by University of Malaya · NCT06871267 · Data updated 2026-11-12
This trial will test a Malaysian-adapted Asian version of the Crohn's Disease Exclusion Diet to see if it improves symptoms and the gut microbiome in people with mild-to-moderate Crohn's disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 74 (estimated) |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur, Petaling Jaya) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | September 10, 2025 |
| Study ends | February 10, 2026 |
| Registry record updated | May 31, 2025 |
| Trial ID | NCT06871267 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed diagnosis of Crohn's disease who have mild-to-moderate disease activity, can give informed consent, and can attend clinic visits at Universiti Malaya Medical Centre are the ideal candidates.
✕Probably not a fit
Patients with severe disease, a stoma, recent gastrointestinal surgery within six months, those on exclusive enteral nutrition, or those unable to adhere to the diet are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled project develops and tests a culturally appropriate Asian version of the Crohn's Disease Exclusion Diet (CDED) for patients at Universiti Malaya Medical Centre. The study includes in-depth interviews to refine diet acceptability, a controlled dietary intervention comparing the modified CDED with a general healthy diet, and microbiome analysis to identify changes after the diet. Participants with confirmed mild-to-moderate Crohn's disease are followed for 24 weeks with visits at 0, 6, 12, and 24 weeks, providing stool and blood samples for clinical, biochemical, and microbiome assessments. Outcomes will include clinical disease activity scores and shifts in gut microbial composition.
Why it matters
Potential benefit: If successful, the adapted diet could reduce symptoms and inflammation, improve remission rates, and produce favorable changes in the gut microbiome using foods acceptable to Malaysian patients.
How similar studies have gone: The CDED has shown benefit in pediatric and some adult Crohn's populations, but applying a culturally adapted Asian version for Malaysian patients is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of Crohn's disease according to established clinical, endoscopic, and histological criteria. * Mild to moderate diseases (150 to 220 points). * Written informed consent obtained. Exclusion Criteria: * Presence of stoma. * Surgery within 6 months prior to randomization. * Patient on exclusive enteral nutrition (EEN).
Where it's running
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Universiti Malaya Medical Centre
Kuala Lumpur, Petaling Jaya, Malaysia Recruiting
Study contacts
- Study coordinator: Ida Normiha Hilmi, MRCP PhD
- Email: ida@ummc.edu.my
- Phone: 0379492868
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.