Dietary Modification In Inflammatory Bowel Disease Patients
ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Malaya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of stoma.
Surgery within 6 months prior to randomization.
Patient on exclusive enteral nutrition (EEN).
Trial design
Design model
Parallel
Treatments tested in this trial
General Healthy Diet
BehavioralParticipants will follow the quarter-quarter-half plate diet as per the Malaysian Healthy Plate guideline.
Crohn's Disease Exclusion Diet (CDED)
BehavioralParticipants will follow the Crohn's Disease Exclusion Diet (CDED), which consists of three phases with specific dietary restrictions.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: General Healthy Diet GroupActive comparator 1 intervention
Group B: Crohn's Disease Exclusion Diet (CDED) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24 weeks2
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.
Time frame
12 weeksSecondary outcomes
1
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.
Time frame
12 weeks2
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.
Time frame
Baseline, Week 6, Week 12, Week 243
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.
Time frame
Week 6, Week 12, Week 24Sponsors and contacts
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Source ClinicalTrials.gov