Risk Factors for Abdominal Pain-Related Disorders of Gut-Brain Interaction in Adults and Children: A Systematic Review.
Jasmine K Zia, Adrienne Lenhart, Pei-Lin Yang...
https://pubmed.ncbi.nlm.nih.gov/35716771/Actively Recruiting
Led by Universiti Kebangsaan Malaysia Medical Centre · Updated on 2026-05-11
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
Functional Gastrointestinal Disorders FGIDs, such as irritable bowel syndrome IBS and functional dyspepsia FD, affect a significant portion of the world and Malaysian populations, impacting quality of life. Researchers are studying how different diets with varying FODMAP content affect gut microbiota, gut barrier function, symptom severity, psychological status, and quality of life in Malaysian FGID patients. This randomized controlled trial aims to compare the effects of a low FODMAP diet, a gentle FODMAP diet, and traditional dietary advice based on NICE guidelines to determine which diet is most suitable for these patients. Participants will be randomly assigned to one of three groups low FODMAP diet, gentle FODMAP diet, or traditional dietary advice. Each group will follow their assigned diet for two weeks. The low FODMAP diet involves swapping high FODMAP foods for low FODMAP alternatives. The gentle FODMAP diet identifies key high FODMAP foods from food diaries and replaces them with low FODMAP alternatives. The traditional dietary advice group follows healthy eating guidelines including regular meals, fluid intake, and limiting certain foods as per NICE IBS guidelines. During the study, participants will attend a baseline visit for screening, questionnaires, body measurements, and collection of stool and blood samples. They will keep a 4-day food diary before and during the intervention. Stool and blood samples will be collected again after the two-week diet period, along with repeated questionnaires assessing symptoms, quality of life, and psychological status. A phone follow-up will check adherence and answer questions. Researchers will analyze changes in gut microbiota, gut barrier function, symptom severity, psychological health, and quality of life to better understand dietary management in FGID.
CONDITIONS
Mechanism of FODMAP Restriction on FGID Patients
S
Shanthi Krishnasamy, Dr
J
Jaysrina Mahalinga Moorthy
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Universiti Kebangsaan Malaysia Medical Centre
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (Day 1)
Participants complete questionnaires, have body measurements and blood samples taken, and provide stool samples before being randomly assigned to one of three diet groups.
1 visit (in-person)
Duration - 2 weeks
Participants follow their assigned diet—Low FODMAP, Gentle FODMAP, or Traditional Dietary Advice—for two weeks while completing food diaries and providing stool samples.
1 visit (in-person) at start and 1 phone follow-up after 1 week
Duration - 1 day (Day 22)
Participants return diaries and stool samples, complete questionnaires, and provide blood samples. Those in the Low FODMAP group receive advice on reintroduction.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor