Malaysian-adapted Asian Crohn's disease diet
Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome
NA · University of Malaya · NCT06871267
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Malaya (other) |
| Locations | 1 site (Kuala Lumpur, Petaling Jaya) |
| Trial ID | NCT06871267 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kuala Lumpur, Petaling Jaya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease