Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Malaysia
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
RECRUITING
Kuala Lumpur
Contact Information
Primary
Shanthi Krishnasamy, Dr
shanthikrishnasamy@ukm.edu.my
+60182017116
Backup
Jaysrina Mahalinga Moorthy
P153921@siswa.ukm.edu.my
+60138372089
Time Frame
Start Date: 2025-07-20
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
Active_comparator: Low FODMAP diet
Low FODMAP diet will be administered for two weeks
Active_comparator: Gentle FODMAP diet
Gentle FODMAP diet will be administered for two weeks
Active_comparator: Traditional Dietary Advice
Traditional Dietary advice will be administered for two weeks
Sponsors
Leads: Universiti Kebangsaan Malaysia Medical Centre

This content was sourced from clinicaltrials.gov