Dietary Modification In Inflammatory Bowel Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-02-10

Brief Summary

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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.

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Detailed Description

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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

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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General Healthy Diet Group

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

Group Type ACTIVE_COMPARATOR

General Healthy Diet

Intervention Type BEHAVIORAL

Participants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline.

Crohn's Disease Exclusion Diet (CDED) Group

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

Group Type EXPERIMENTAL

Crohn's Disease Exclusion Diet (CDED)

Intervention Type BEHAVIORAL

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

Interventions

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General Healthy Diet

Participants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.