NCT07000227 Mechanism of FODMAP Restriction on FGID Patients
| NCT ID | NCT07000227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre |
| Condition | Functional Gastrointestinal Disorders (FGIDs) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-07-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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)
Contact & Investigator
Neoh Hui-Min, Assc. Prf
STUDY CHAIR
National University of Malaysia
Frequently Asked Questions
Who can join the NCT07000227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Functional Gastrointestinal Disorders (FGIDs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07000227 currently recruiting?
Yes, NCT07000227 is actively recruiting participants. Contact the research team at shanthikrishnasamy@ukm.edu.my for enrollment information.
Where is the NCT07000227 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT07000227 clinical trial?
NCT07000227 is sponsored by Universiti Kebangsaan Malaysia Medical Centre. The principal investigator is Neoh Hui-Min, Assc. Prf at National University of Malaysia. The trial plans to enroll 60 participants.