Status:
RECRUITING
Mechanism of FODMAP Restriction on FGID Patients
Lead Sponsor:
Universiti Kebangsaan Malaysia Medical Centre
Conditions:
Functional Gastrointestinal Disorders (FGIDs)
Irritable Bowel Syndrome (IBS)
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
Detailed Description
Functional Gastrointestinal Disorder (FGIDs), including irritable bowel syndrome (IBS) and functional dyspepsia (FD), are prevalent conditions that effects about 40% of world population and 21% of Mal...
Eligibility Criteria
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
- 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)
Key Trial Info
Start Date :
July 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07000227
Start Date
July 20 2025
End Date
September 30 2026
Last Update
August 12 2025
Active Locations (1)
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1
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000