RecruitingNot Applicable

Mechanism of FODMAP Restriction on FGID Patients

Malaysia60 participantsStarted 2025-07-20

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 they're measuring

Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity

Timeframe: Measurement before (Day 1) and after the diet (Day 22)

Effect of FODMAP restrictions on Gut Barrier Function

Timeframe: Measurement before (Day 1) and after the diet (Day 22)

Trial details

NCT IDNCT07000227

SponsorUniversiti Kebangsaan Malaysia Medical Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Shanthi Krishnasamy, Dr

+60182017116 shanthikrishnasamy@ukm.edu.my