Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07000227

Mechanism of FODMAP Restriction on FGID Patients

Led by Universiti Kebangsaan Malaysia Medical Centre · Updated on 2026-05-11

60

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Mechanism of FODMAP Restriction on FGID Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak

Kuala Lumpur, Kuala Lumpur, Malaysia, 56000

Actively Recruiting

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Research Team

S

Shanthi Krishnasamy, Dr

CONTACT

J

Jaysrina Mahalinga Moorthy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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