How different FODMAP diets affect people with IBS and functional dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized dietary trial in Kuala Lumpur will assign adults with FGID to a low FODMAP diet, a gentle FODMAP diet, or traditional dietary advice for two weeks. Participants will provide stool and blood samples at baseline and during the intervention, keep a 4-day food diary, and complete symptom, quality-of-life, and psychological questionnaires. The study will compare gut microbiota composition and diversity, markers of gut barrier function, symptom severity, quality of life, and psychological status across the three groups. Results aim to identify which dietary approach is most suitable and effective for Malaysian FGID patients and to clarify underlying microbiota and barrier changes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
  Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Study coordinator: Shanthi Krishnasamy, Dr
• Email: shanthikrishnasamy@ukm.edu.my
• Phone: +60182017116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.