How different FODMAP diets affect people with IBS and functional dyspepsia
Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial
This test will try low FODMAP, gentle FODMAP, and standard dietary advice in adults with IBS or functional dyspepsia to see how they change symptoms, gut bacteria, gut barrier function, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre Academic / other |
| Locations | 1 site (Kuala Lumpur, Kuala Lumpur) |
| Trial ID | NCT07000227 on ClinicalTrials.gov |
What this trial studies
This randomized dietary trial in Kuala Lumpur will assign adults with FGID to a low FODMAP diet, a gentle FODMAP diet, or traditional dietary advice for two weeks. Participants will provide stool and blood samples at baseline and during the intervention, keep a 4-day food diary, and complete symptom, quality-of-life, and psychological questionnaires. The study will compare gut microbiota composition and diversity, markers of gut barrier function, symptom severity, quality of life, and psychological status across the three groups. Results aim to identify which dietary approach is most suitable and effective for Malaysian FGID patients and to clarify underlying microbiota and barrier changes.
Who should consider this trial
Good fit: Adults aged 18 or older with a gastroenterologist-diagnosed diagnosis of IBS or functional dyspepsia who meet Rome III-Asian criteria, can give informed consent, and can communicate in Malay or English are ideal candidates.
Not a fit: Patients who are pregnant or lactating, have inflammatory bowel disease, celiac disease, recent major GI resection, active cancer, are on recent antibiotics or regular opioids, or use probiotics/prebiotics are excluded and unlikely to benefit from this dietary comparison.
Why it matters
Potential benefit: If successful, this could identify a culturally appropriate dietary approach that reduces symptoms and improves quality of life for Malaysian FGID patients while clarifying related gut microbiota and barrier changes.
How similar studies have performed: Low FODMAP diets have reduced IBS symptoms in multiple Western trials, but head-to-head comparisons with Gentle FODMAP or standard advice and data from Asian populations remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 and above * Able to provide informed consent * Those with pre-existing 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 Exclusion Criteria: * Pregnant or lactating women * History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis * Cancer of any kind * Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma * Habitual use of opiate analgesics likely to alter bowel function e.g. morphine * Use of antibiotics in the preceding two weeks and/or in the past one month * Consumption of probiotics, prebiotics or fibre supplements in the past one month * Enteral feeding or texture modified diet patients * Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc) * Shift workers (e.g. Nurse, doctors)
Where this trial is running
Kuala Lumpur, Kuala Lumpur
- Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Study coordinator: Shanthi Krishnasamy, Dr
- Email: shanthikrishnasamy@ukm.edu.my
- Phone: +60182017116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.