Dietary Modification In Inflammatory Bowel Disease Patients
Not applicable · Testing General Healthy Diet and Crohn's Disease Exclusion Diet (CDED) · 1 site · University of Malaya
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing General Healthy Diet (a behavioral program) and Crohn's Disease Exclusion Diet (CDED) (a behavioral program) as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 50
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 74 participants are expected to take part.
- Start date: 2025-03-01.
- Main results expected around 2025-09-10 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Malaysia.
Main thing being measured
- To improve the Asian Inflammatory Bowel Disease diet. (24 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | University of Malaya |
| Enrollment | 74 (estimated) |
| Start date | 2025-03-01 |
| Primary completion (est.) | 2025-09-10 |
| First posted | 2025-03-11 |
| Last updated | 2025-05-31 |
| Official title | Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome |
| ClinicalTrials.gov ID | NCT06871267 |
Interventions
- 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.
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Universiti Malaya Medical Centre | Kuala Lumpur, Petaling Jaya | Malaysia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.