Clinical trial NCT06871267: Dietary Modification In Inflammatory Bowel Disease Patients
Official title: Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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).

Primary outcomes:
measure: To improve the Asian Inflammatory Bowel Disease diet.
timeFrame: 24 weeks
measure: Number of Participants Achieving Clinical Response at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Fecal Calprotectin Concentration from Baseline to Post-Intervention
timeFrame: 12 weeks
measure: Changes in Gut Microbiota Composition Over Time (Baseline, Week 6, Week 12, Week 24)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Differential Distribution of Gut Microbiota Between Control and Intervention Groups at Weeks 6, 12, and 24
timeFrame: Week 6, Week 12, Week 24
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
state: Petaling Jaya
Study officials:
References: