Testing a diet for people with Crohn disease and gut bacteria changes
Tests a Malaysian version of an exclusion diet in adults with Crohn disease.
Key facts
- Who runs it
- University of Malaya
- Where
- Kuala Lumpur, MalaysiaSee the site
- Trial code
- Registry title
- Dietary Modification In Inflammatory Bowel Disease Patients
- Status
- Recruiting
- People taking part
- 74 people, planned
- Started
- 1 Mar 2025
- Planned end
- 10 Feb 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- General Healthy Diet
- Crohn's Disease Exclusion Diet (CDED)
- Record updated
- 31 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 50 with Crohn's disease that is mild to moderate. It tests a Crohn's disease exclusion diet against a general healthy diet.
- Age
- 18 Years to 50 Years
- Sex
- All sexes can join.
- Disease stage
- Crohn's disease confirmed by clinical, endoscopic and histological criteria. Mild to moderate disease (150 to 220 points).
- Earlier treatment
- People who had surgery within 6 months before randomization cannot join. People on exclusive enteral nutrition (EEN) cannot join.
Main reasons for not taking part
- Has a stoma
- Had surgery within 6 months before randomization
- Is on exclusive enteral nutrition (EEN)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Surgery within 6 months prior to randomization
- Presence of stoma
- Patient on exclusive enteral nutrition (EEN)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in Malaysia
- Universiti Malaya Medical CentreKuala Lumpur, MalaysiaContact: Ida HilmiTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- General Healthy Diet GroupExisting treatment, for comparison
Participants in this group will follow the quarter-quarter-half plate diet based on the Malaysian Healthy Plate guideline.
Treatment: General Healthy Diet
- Crohn's Disease Exclusion Diet (CDED) GroupTreatment being tested
Participants in this group will follow the Crohn's Disease Exclusion Diet (CDED), which consists of three phases with specific dietary restrictions.
Treatment: Crohn's Disease Exclusion Diet (CDED)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome
- Plain-language title
- Testing a diet for people with Crohn disease and gut bacteria changesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06871267, who can take part
- Record updated
- 31 May 2025