Dietary Modification In Inflammatory Bowel Disease Patients

May 27, 2025 updated by: University of Malaya

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ida Normiha Hilmi, MRCP PhD
  • Phone Number: 0379492868
  • Email: ida@ummc.edu.my

Study Contact Backup

Study Locations

  • Malaysia
    • Petaling Jaya
      • Kuala Lumpur, Petaling Jaya, Malaysia, 50603
        • Recruiting
        • Universiti Malaya Medical Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General Healthy Diet Group
Participants in this group will follow the quarter-quarter-half plate diet based on the Malaysian Healthy Plate guideline.
Behavioral: General Healthy Diet
Participants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To improve the Asian Inflammatory Bowel Disease diet.
Time Frame: 24 weeks
Implementing improvised dietary guidance based on CDED is suitable for Asian settings to see patients' adherence (%) based on the diet adherence rating scale questionnaire.
24 weeks
Number of Participants Achieving Clinical Response at Week 12
Time Frame: 12 weeks
Clinical response will be assessed based on Crohn's Disease Activity Index (CDAI) score. An improvement of clinical response is defined as <150 CDAI score at week 12.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal Calprotectin Concentration from Baseline to Post-Intervention
Time Frame: 12 weeks
The effectiveness of the diet will be assessed by measuring fecal calprotectin concentration (mg/kg) at baseline and after the 12-week intervention.
12 weeks
Changes in Gut Microbiota Composition Over Time (Baseline, Week 6, Week 12, Week 24)
Time Frame: Baseline, Week 6, Week 12, Week 24
The gut microbiota composition of participants will be assessed at Baseline, Week 6, Week 12, and Week 24 using 16S rRNA sequencing and shotgun metagenomics. Changes in microbiota composition will be evaluated based on relative abundance (%) of bacterial taxa at the genus/species level.
Baseline, Week 6, Week 12, Week 24
Differential Distribution of Gut Microbiota Between Control and Intervention Groups at Weeks 6, 12, and 24
Time Frame: Week 6, Week 12, Week 24
The gut microbiota composition of participants following the Crohn's Disease Exclusion Diet (CDED) will be compared to those following the General Healthy Diet at multiple time points (Week 6, Week 12, and Week 24). Between-group differences will be evaluated based on relative abundance (%) of bacterial taxa at the genus/species level.
Week 6, Week 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

September 10, 2025

Study Completion (Estimated)

February 10, 2026

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024321-13563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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