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NCT Number: NCT06871267

Dietary Modification In Inflammatory Bowel Disease Patients

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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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malaya Medical Centre

Kuala Lumpur, Petaling Jaya, 50603, Malaysia

Location status: Recruiting

Location contact

Ida Hilmi

CONTACT

[email protected]

+0379492965

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

General Healthy Diet

Behavioral

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

Crohn's Disease Exclusion Diet (CDED)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ida Normiha Hilmi, MRCP PhD

CONTACT

[email protected]

0379492868

Nazihah Wafi, BMedSci

CONTACT

[email protected]

0138058802

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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