NCT06871267 Dietary Modification In Inflammatory Bowel Disease Patients
| NCT ID | NCT06871267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Malaya |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-09-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This research project aimed to develop a culturally appropriate Asian Inflammatory Bowel Disease Diet for the Malaysian population, based on the Crohn's disease exclusion diet (CDED). The study will be conducted in inflammatory bowel disease patients in University Malaya Medical Centre, which are ulcerative colitis and Crohn's disease patients. The objectives of this study are to assess the impact of diet in clinical outcome and gut microbiota changes in patients with inflammatory bowel disease (IBD). The study duration spans 24 weeks, during which comprehensive follow-ups will be conducted at 0, 6, 12, and 24 weeks, respectively. At each follow-up session, participants will be requested to provide stool and blood samples for meticulous assessment of clinical and biochemical responses.
Eligibility 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).