Mechanism of FODMAP Restriction on FGID Patients

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

Conditions

• Functional Gastrointestinal Disorders (FGIDs)
• Irritable Bowel Syndrome (IBS)
• Functional Dyspepsia

Interventions

BEHAVIORAL

Low FODMAP diet

High FODMAP foods are swapped for low FODMAP alternatives, for two weeks (Elimination phase)

BEHAVIORAL

Gentle FODMAP diet

Key High FODMAP foods will be identified from patients' food diaries and swapped with low FODMAP alternatives. (Elimination phase)

BEHAVIORAL

Traditional Dietary Advice

Subjects are required to follow a set of healthy eating guidelines set by NICE guidelines for IBS for two weeks a. Have regular meals and take time to eat b. Avoid missing meals or leaving long gaps between eating c. Drink at least eight cups of fluid a day, especially water or other non-d. caffeinated drinks, such as herbal teas d. Restrict tea and coffee to three cups a day e. Reduce intake of alcohol and fizzy drinks . Limit intake of high-fibre food g. Reduce intake of resistant starch h. Limit fresh fruit to three portions a day

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre

  lead OTHER

Principal Investigators

• Neoh Hui-Min, Assc. Prf · National University of Malaysia

• Vanitha Mariappan, Dr · National University of Malaysia

• Deborah Chia Hsin Chew, Dr · National University of Malaysia

• Syaratul Dalina Yusoff, Dr · National University of Malaysia

• Yee Xing You, Dr · National University of Malaysia

• Yeong Yeh Lee, Prof · Universiti Sains Malaysia

• Jaysrina Mahalinga Moorthy, Ms · National University of Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-20

Primary Completion

2026-06-30

Completion

2026-09-30

Countries

• Malaysia

Study Locations