Mechanism of FODMAP Restriction on FGID Patients

Launched by UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of diets, specifically those that limit certain carbohydrates known as FODMAPs, can affect patients with Functional Gastrointestinal Disorders (FGIDs) like Irritable Bowel Syndrome (IBS) and Functional Dyspepsia. The researchers want to understand how these diets impact gut health, symptoms, and overall well-being. Participants will be assigned to one of three diets: a low FODMAP diet, a Gentle FODMAP diet, or Traditional Dietary Advice based on current guidelines. They will follow their assigned diet for two weeks and will provide stool and blood samples, along with keeping a food diary and filling out questionnaires about their health.

To be eligible for this trial, participants need to be at least 18 years old and able to give consent. They should have IBS or Functional Dyspepsia as diagnosed by a doctor and be able to communicate in Malay or English. Certain individuals, such as those who are pregnant, have specific gastrointestinal diseases, or are currently taking certain medications, will not be able to participate. This trial is currently in the planning stage and has not yet started recruiting participants.

Gender

ALL

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)