Mechanism of FODMAP Restriction on FGID Patients
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- Who runs it
- Universiti Kebangsaan Malaysia Medical Centre
- Trial code
- NCT07000227
- Record updated
- 25 September 2026
- Original description
Brief Summary :Read full original descriptionShow less
Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial
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
Inclusion: 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: Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma; 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; Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc); Pregnant or lactating women; 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; Shift workers (e.g. Nurse, doctors).