Mechanism of FODMAP Restriction on FGID Patients
Recruiting now · Not applicable
Conditions studied: Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS), Functional Dyspepsia
In brief
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
Key facts
- Study ID
- NCT07000227
- Run by
- Universiti Kebangsaan Malaysia Medical Centre
- People needed
- 60
- Starts
- 2025-07-20
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
Full record on ClinicalTrials.gov
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