Dietary Modification In Inflammatory Bowel Disease Patients

University of Malaya

Status: Enrolling

Conditions: Crohn Disease

Treatments: Behavioral: Crohn's Disease Exclusion Diet (CDED); Behavioral: General Healthy Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06871267

2024321-13563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

General Healthy Diet Group

Active Comparator group

Description:

Participants in this group will follow the quarter-quarter-half plate diet based on the Malaysian Healthy Plate guideline.

Treatment:

Behavioral: General Healthy Diet

Crohn's Disease Exclusion Diet (CDED) Group

Experimental group

Description:

Participants in this group will follow the Crohn's Disease Exclusion Diet (CDED), which consists of three phases with specific dietary restrictions.

Treatment:

Behavioral: Crohn's Disease Exclusion Diet (CDED)