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/35716771Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07000227
Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients: A Randomised Controlled Trial
Led by Universiti Kebangsaan Malaysia Medical Centre · Updated on 2026-05-11
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Mechanism of FODMAP Restriction on FGID Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 and above
- Able to provide informed consent
- Diagnosed with irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both, screened by gastroenterologists
- Meet the ROME III-Asian criteria for FGID
- Able to communicate in Malay or English language
You will not qualify if you...
- Pregnant or lactating women
- History of gastrointestinal disorders such as Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease, Diverticulitis
- Any type of cancer
- Previous resection of any part of the GI tract except appendix or gall bladder, or intestinal stoma
- Habitual use of opiate analgesics like morphine
- Use of antibiotics within the past two weeks or in the past month
- Consumption of probiotics, prebiotics, or fiber supplements in the past month
- Receiving enteral feeding or on texture-modified diets
- Cognitive impairment or severe mental disorders such as Alzheimer’s, schizophrenia, bipolar disorder
- Shift workers including nurses and doctors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Data Collection and Randomisation
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)
Dietary Intervention
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
Final Assessment
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)
Trial Site Locations
Total: 1 location
1
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
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Research Team
S
Shanthi Krishnasamy, Dr
J
Jaysrina Mahalinga Moorthy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Christopher J Black, Douglas A Drossman, Nicholas J Talley...
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