Mechanism of FODMAP Restriction on FGID Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversiti Kebangsaan Malaysia Medical Centre

About this 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Low FODMAP diet
  • Gentle FODMAP diet
  • Traditional Dietary Advice

Treatment groups

60 Participants
are divided into 3 treatment groups