Mechanism of FODMAP Restriction on FGID Patients
Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial
- Functional Gastrointestinal Disorders (FGIDs)
- Irritable Bowel Syndrome (IBS)
- Functional Dyspepsia
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Enrolment target
- 60
- Started
- 20 July 2025
- Main results due
- 24 September 2026
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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)
What this study is about
In the sponsor’s own words, from the registry.
Brief Summary :
The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :
How does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.
Participants will :
Be given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.
Be required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention
Study sites(1)
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur, Kuala Lumpur, Malaysia
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07000227. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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