Mechanism of FODMAP Restriction on FGID Patients (BRIDGE)

May 8, 2026 updated by: Dr Shanthi Krishnasamy, Universiti Kebangsaan Malaysia Medical Centre

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Functional Gastrointestinal Disorder (FGIDs), including irritable bowel syndrome (IBS) and functional dyspepsia (FD), are prevalent conditions that effects about 40% of world population and 21% of Malaysian population. They represent a significant health burden, impacting patients' quality of life. While the low FODMAP diet is effective in managing FGID around the western region, there is limited research done on comparing the impacts of diets with differing FODMAP content on symptom severity, quality of life, gut microbiota and gut barrier function of FGID patients in the Asian region as low FODMAP is restrictive. Therefore, conducting a randomised controlled trial is vital in measuring the effectiveness of diet with differing FODMAPs on FGID patients.

The objectives of this study are :

  • To determine the effect of FODMAPs restriction on the gut microbiota abundance and diversity in FGID patients
  • To determine the effect of FODMAPs restriction on gut barrier function after dietary intervention among FGID patients
  • To determine the effect of FODMAPs restriction on the symptom severity, quality of life and psychological status in FGID patients

This study would be able to provide significant understanding of dietary management of FGID. Conducting this study would provide critical insights into the role of gut microbiota and gut barrier function in the pathophysiology of FGID, highlighting how dietary modulation can impact overall symptom management.

The study design involve screening and recruiting participants, followed by baseline data collection, randomisation, group allocation, and intervention with data collection.

First Visit (Day 1) During baseline, vital information such as socio demographic data will be gathered and FGID screening will be conducted using the ROME III Asian Diagnostic Questionnaire for Adults which consists of the Irritable Bowel Syndrome module and the Gastroduodenal Disorders module. A total of 5 questionnaires will be provide to the participants. These are Irritable Bowel Syndrome Severity Scale (IBS-SSS), Gastrointestinal Symptom Rating Scale (GSRS), Food avoidance and Dietary trigger questionnaire, Hospital Anxiety and Depression Scale (HADS), and the EQ-5D-5L questionnaire.

Body weight and composition of participants will be assessed using the Tanita Body Composition scale, whereas height of participants will be measured using a stadiometer. Dietary and FODMAPs will be estimated using a 4-day food diary (3 weekdays, 1 weekend). Additionally, blood sample will be collected from participants for further assessment. 10 ml blood will be drawn from each participant to detect serum biomarkers. Stool bottle will be provided to participants for stool collection upon the next visit. Stool collection is implemented to assess participants' gut integrity and gut microbiota. After concluding the baseline assessments, patients will be randomised into three groups. Groups A, B and C will follow a restricted FODMAP diet (LFD), Gentle FODMAP diet and traditional dietary advice (TDA), respectively. Participants will be randomly assigned to a study arm by a computer-generated randomisation program using the open-access website www.randomization.com at a ratio of 1:1:1.

Second Visit (Day 8) Participants will return their stool sample and completed diary. The diary will be assessed for completion, and the stool sample will be collected and frozen per protocol. Based on randomisation, participants in the LFD group will be provided with restricted FODMAP advice. In contrast, those in the GFD group will be given general healthy advice by dietitians/researchers trained in delivering the diet. Meanwhile, participants in the TDA group will be given an overall healthy dietary intervention and counselling. All three groups will be advised to follow their respective diets for two weeks. A food diary and another stool collection bottle will be provided.

Phone follow up (Day 15) A phone follow-up is scheduled after a week to remind participants to complete their food diary, answer any doubts or questions relating to their allocated intervention and subsequently plan their next visit.

Final visit (Day 22) Visit 3 will be scheduled after 2 weeks of intervention. Participants will return their stool samples, food diary, and questionnaire. They will also complete two symptom severity questionnaires, food avoidance and dietary trigger questionnaire, with questionnaires to assess quality of life and psychological status and provide a non-fasting blood sample. Additionally, participants in the LFD group will be provided advice on reintroduction. Those who have completed the study will be given an inconvenience allowance.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaysrina Mahalinga Moorthy, Ms

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low FODMAP diet
Low FODMAP diet will be administered for two weeks
Behavioral: Low FODMAP diet
High FODMAP foods are swapped for low FODMAP alternatives, for two weeks (Elimination phase)
Active Comparator: Gentle FODMAP diet
Gentle FODMAP diet will be administered for two weeks
Behavioral: Gentle FODMAP diet
Key High FODMAP foods will be identified from patients' food diaries and swapped with low FODMAP alternatives. (Elimination phase)
Active Comparator: Traditional Dietary Advice
Traditional Dietary advice will be administered for two weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
16s RNA gene seqeuncing will be conducted on the stool samples at both baseline and post-intervention timelines. This test would target the microbial diversity by assessing the abdundance of key bacterial taxa.
Measurement before (Day 1) and after the diet (Day 22)
Effect of FODMAP restrictions on Gut Barrier Function
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
The stool samples collected would be subjected to zonulin test and short-chain fatty acid quantification (SCFA) in order to assess gut barrier function of subjects at baseline and post-intervention timelines. Zonulin is a protein that reversibly modulates the intestinal permeability, while SCFA such as butyrate are by-products of the carbohydrate fermentation facilitated by gut microbiome that enhances the integrity of tight junction of the intestinal barrier
Measurement before (Day 1) and after the diet (Day 22)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of 2 week FODMAP restrictions on Symptom Severity (IBS-SSS questionnaire)
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS) will be filled out by subjects during baseline and post-intervention to assess symptom severity. For IBS-SSS, Four out of five items have visual analogue scales to describe the level of severity of abdominal pain, bloating or distension, disturbance of bowel habits and life impact of IBS symptoms. The level of severity will be categorised based on their total scores. A score of less than 25% is considered no pain, 25 to 50% is considered mild, 50 to 75% is considered moderate, and the score of 100% is very severe.
Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restriction on Psychological Status
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
Hospital Anxiety and Depression Scale (HADS) will be filled out by subjects during baseline and post-intervention to assess symptom severity. This self-reported questionnaire contains 14 items that are scored on a 4-point Likert-type scale, ranging from 0 to 3, and are classified into two subscales measuring cognitive and emotional symptoms of depression (HADS-D) and anxiety (HADS-A). The total score on each subscale ranges from 0 to 21, and a higher score represents worse symptoms. A score equal to or greater than eight on either HADS-D or HADS-A is considered a 'possible case', and above 11 a 'probable case'.
Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restriction on Quality of Life
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
European Quality of Life 5 Dimensions 5 Level Version Questionnaire (EQ-5D-5L) will be filled out by subjects during baseline and post-intervention to assess quality of life. This validated questionnaire consists of five items capturing different aspects of health, including mobility, self-care, ability to carry out usual activities, pain/discomfort and anxiety/depression. Each item has five levels of responses, where the minimum level being 'no problems' and maximum level being 'unable to do' things mentioned.
Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restriction on Food Avoidance
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
A validated food avoidance and dietary trigger questionnaire will be filled out by subjects during baseline and post-intervention to assess food avoidance. This questionnaire is a 10-item tool in which question 1 is to identify dietary triggers of subjects. Question 2, 3, and 4 are follow up questions to assess bowel symptoms and dietary triggers. Question 5 that assess fear of eating, has a 6-point Likert scale, where the minimum point is 'Strongly Disagree' and the maximum point is 'Strongly Agree'.Question 6 assesses food avoidance behaviour using a 4-point Likert scale, where the minimum point is 'Never' and the maximum point is 'Always'. Questions 6,7,8,9 and 10 are used to assess patient's medical knowledge and medical history.
Measurement before (Day 1) and after the diet (Day 22)
Effect of 2 week FODMAP restrictions on Anthropometry
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
The anthropometry parameters such as weight (in kilograms), height (in centimetres), and body mass index (BMI) (kg/m^2) will be assessed using standard protocols. To measure changes in body composition, weight, and BMI, the Body Impedance Analysis (BIA) will be used. Parameters such as percentage of body fat (%), visceral fat, muscle mass (kg) and total body water (%) will be measured.
Measurement before (Day 1) and after the diet (Day 22)
FODMAP Intake Before and After Intervention
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
FODMAP intake will be estimated from the 4-day food diary (3 weekdays, 1 weekend) given to subjects both before intervention and after following 2-week intervention. FODMAP intake will be estimated using the Monash University Database
Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restrictions on Symptom Severity (GSRS questionnaire)
Time Frame: Measurement before (Day 1) and after the diet (Day 22)
The Gastrointestinal Symptom Rating Scale (GSRS) will be filled out by subjects during baseline and post-intervention to assess symptom severity. GSRS is 13 item questionnaire that are scored on a 7-point Likert scale, with the minimum point being 'no discomfort at all' and maximum value being 'very severe discomfort'.
Measurement before (Day 1) and after the diet (Day 22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Study Chair: Neoh Hui-Min, Assc. Prf, National University of Malaysia
  • Study Chair: Vanitha Mariappan, Dr, National University of Malaysia
  • Study Chair: Deborah Chia Hsin Chew, Dr, National University of Malaysia
  • Study Chair: Syaratul Dalina Yusoff, Dr, National University of Malaysia
  • Study Chair: Yee Xing You, Dr, National University of Malaysia
  • Study Chair: Yeong Yeh Lee, Prof, Universiti Sains Malaysia
  • Study Director: Jaysrina Mahalinga Moorthy, Ms, National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 5, 2025

First Submitted That Met QC Criteria

May 28, 2025

First Posted (Actual)

June 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEP-2024-1144
  • FRGS/1/2023/SKK06/UKM/03/4 (Other Grant/Funding Number: Ministry of Higher Education Malaysia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not be sharing individual patient data to the trial registry to protect participant confidentiality, as institutional policies restrict such disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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