Dietary Modification In Inflammatory Bowel Disease Patients

NCT06871267 | Recruiting DMC

• 1 other identifier: 2024321-13563
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• To improve the Asian Inflammatory Bowel Disease diet.

  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

  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 Outcomes (3)

• Change in Fecal Calprotectin Concentration from Baseline to Post-Intervention

  12 weeks

• Changes in Gut Microbiota Composition Over Time (Baseline, Week 6, Week 12, Week 24)

  Baseline, Week 6, Week 12, Week 24

• Differential Distribution of Gut Microbiota Between Control and Intervention Groups at Weeks 6, 12, and 24

  Week 6, Week 12, Week 24

Study Arms (2)

General Healthy Diet Group

ACTIVE COMPARATOR

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

Behavioral: General Healthy Diet

Crohn's Disease Exclusion Diet (CDED) Group

EXPERIMENTAL

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)

Interventions

General Healthy Diet BEHAVIORAL

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

General Healthy Diet Group

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.

Crohn's Disease Exclusion Diet (CDED) Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Presence of stoma.
• Surgery within 6 months prior to randomization.
• Patient on exclusive enteral nutrition (EEN).

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya Medical Centre

Kuala Lumpur, Petaling Jaya, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Ida Normiha Hilmi, MRCP PhD

CONTACT

0379492868; ida@ummc.edu.my

Nazihah Wafi, BMedSci

CONTACT

0138058802; nazihahwafi@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion: September 10, 2025
• Study Completion: February 10, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)