Crohn DiseaseNCT06871267
Dietary Modification In Inflammatory Bowel Disease Patients
A study testing General Healthy Diet and Crohn's Disease Exclusion Diet (CDED) in people with Crohn Disease, run by University of Malaya at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- General Healthy Diet and Crohn's Disease Exclusion Diet (CDED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- Presence of stoma.
- Surgery within 6 months prior to randomization.
- Patient on exclusive enteral nutrition (EEN).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Malaya Medical Centre
Kuala Lumpur, Petaling Jaya, 50603
Ida Hilmi, +0379492965, ida@ummc.edu.my
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- General Healthy Diet, Crohn's Disease Exclusion Diet (CDED)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Healthy DietBehavioural
Participants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline.
Crohn's Disease Exclusion Diet (CDED)Behavioural
Participants will follow the Crohn's Disease Exclusion Diet (CDED), which consists of three phases with specific dietary restrictions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Crohn's Disease Exclusion Diet (CDED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
Change in Fecal Calprotectin Concentration from Baseline to Post-Intervention
The effectiveness of the diet will be assessed by measuring fecal calprotectin concentration (mg/kg) at baseline and after the 12-week intervention.
Measured: 12 weeks
Changes in Gut Microbiota Composition Over Time (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.
Measured: Baseline, Week 6, Week 12, Week 24
Differential Distribution of Gut Microbiota Between Control and Intervention Groups at Weeks 6, 12, and 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.
Measured: Week 6, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Mar 2025
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871267
- Sponsor's protocol ID
- 2024321-13563
- Status last verified
- May 2025
- First submitted
- 24 Feb 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Modification In Patients With Inflammatory Bowel Diseases And Its Impact In Gut Microbiome
- ClinicalTrials.gov ID
- NCT06871267
- Acronym / sponsor ID
- 2024321-13563
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Healthy Diet Group | Active comparator | Behavioral: General Healthy DietParticipants in this group will follow the quarter-quarter-half plate diet based on the Malaysian Healthy Plate guideline. |
| Crohn's Disease Exclusion Diet (CDED) Group | Experimental | Behavioral: Crohn's Disease Exclusion Diet (CDED)Participants in this group will follow the Crohn's Disease Exclusion Diet (CDED), which consists of three phases with specific dietary restrictions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of stoma.
- Surgery within 6 months prior to randomization.
- Patient on exclusive enteral nutrition (EEN).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Healthy DietParticipants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline. | Behavioural | General Healthy Diet Group |
| 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. | Behavioural | Crohn's Disease Exclusion Diet (CDED) Group |
Primary outcome
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.
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.
3 secondary outcomes
Change in Fecal Calprotectin Concentration from Baseline to Post-Intervention
Time frame: 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
Differential Distribution of Gut Microbiota Between Control and Intervention Groups at Weeks 6, 12, and 24
Time frame: Week 6, Week 12, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Healthy Diet and Crohn's Disease Exclusion Diet (CDED) in people with Crohn Disease, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida Normiha Hilmi, MRCP PhD (0379492868, ida@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To improve the Asian Inflammatory Bowel Disease diet. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.