NCT06871267

Dietary Modification In Inflammatory Bowel Disease Patients

Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Inflammatory bowel disease is a chronic gut inflammation due to immune system dysregulation. Although the exact causes remain unknown, patients' dietary habits were shown to affect the disease activity depending on the food exposure, either proinflammatory or anti-inflammatory food. This randomized-controlled trial (RCT) study aims to improve the modified CDED diet that is acceptable for the Malaysian population at Universiti Malaya Medical Centre. This study comprised of three parts: (Part 1: In-depth interview to measure the acceptance of the diet, Part 2: Implementation of the CDED diet, Part 3: Identification of change in gut microbiome post dietary intervention). The duration of the study is two years.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BEHAVIORAL	General Healthy Diet	Participants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline.
BEHAVIORAL	Crohn's Disease Exclusion Diet (CDED)	Participants will follow the Crohn's Disease Exclusion Diet (CDED), which consists of three phases with specific dietary restrictions.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-09-10
• Completion: 2026-02-10
• First posted: 2025-03-11
• Last updated: 2025-05-31

Locations

1 site across 1 country: Malaysia