Functional Gastrointestinal Disorders (FGIDs)BRIDGENCT07000227
Mechanism of FODMAP Restriction on FGID Patients
A study testing Low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice in people with Functional Gastrointestinal Disorders (FGIDs) and Irritable Bowel Syndrome (IBS), run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS), Functional Dyspepsia
- What is being tested?
- Low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Jul 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur, Kuala Lumpur, 56000
Shanthi Krishnasamy, Dr, +60182017116, shanthikrishnasamy@ukm.edu.my
Jaysrina Mahalinga Moorthy, +60138372089, P153921@siswa.ukm.edu.my
About this study
Official title: 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 :
Read more
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
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS), Functional Dyspepsia
- Being tested
- Low FODMAP diet, Gentle FODMAP diet, Traditional Dietary Advice
- Keywords
- Functional Gastrointestinal Disorder, Irritable Bowel Syndrome, Functional Dyspepsia, FODMAP Restriction, Gentle FODMAP
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP dietBehavioural
High FODMAP foods are swapped for low FODMAP alternatives, for two weeks (Elimination phase)
Gentle FODMAP dietBehavioural
Key High FODMAP foods will be identified from patients' food diaries and swapped with low FODMAP alternatives. (Elimination phase)
Traditional Dietary AdviceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP diet | Active comparator | Low FODMAP diet will be administered for two weeks Receives: Behavioral: Low FODMAP diet |
| Gentle FODMAP diet | Active comparator | Gentle FODMAP diet will be administered for two weeks Receives: Behavioral: Gentle FODMAP diet |
| Traditional Dietary Advice | Active comparator | Traditional Dietary advice will be administered for two weeks Receives: Behavioral: Traditional Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity
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.
Measured: Measurement before (Day 1) and after the diet (Day 22)
Effect of FODMAP restrictions on Gut Barrier Function
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
Measured: Measurement before (Day 1) and after the diet (Day 22)
Secondary outcomes (7)
Effect of 2 week FODMAP restrictions on Symptom Severity (IBS-SSS questionnaire)
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.
Measured: Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restriction on Psychological Status
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'.
Measured: Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restriction on Quality of Life
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.
Measured: Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restriction on Food Avoidance
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.
Measured: Measurement before (Day 1) and after the diet (Day 22)
Effect of 2 week FODMAP restrictions on Anthropometry
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.
Measured: Measurement before (Day 1) and after the diet (Day 22)
FODMAP Intake Before and After Intervention
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
Measured: Measurement before (Day 1) and after the diet (Day 22)
Effect of 2-week FODMAP restrictions on Symptom Severity (GSRS questionnaire)
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'.
Measured: Measurement before (Day 1) and after the diet (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start20 Jul 2025
- Primary completion24 Sep 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal Disorders (FGIDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shanthi Krishnasamy, Universiti Kebangsaan Malaysia Medical Centre
- Investigators
- Neoh Hui-Min, Assc. Prf, Study chair, National University of MalaysiaVanitha Mariappan, Dr, Study chair, National University of MalaysiaDeborah Chia Hsin Chew, Dr, Study chair, National University of MalaysiaSyaratul Dalina Yusoff, Dr, Study chair, National University of MalaysiaYee Xing You, Dr, Study chair, National University of MalaysiaYeong Yeh Lee, Prof, Study chair, Universiti Sains MalaysiaJaysrina Mahalinga Moorthy, Ms, Study director, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000227
- Sponsor's protocol ID
- JEP-2024-1144
- Other IDs
- FRGS/1/2023/SKK06/UKM/03/4
- Acronym
- BRIDGE
- Status last verified
- May 2026
- First submitted
- 5 May 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual patient data to the trial registry to protect participant confidentiality, as institutional policies restrict such disclosure.
Publications
Zia JK, Lenhart A, Yang PL, Heitkemper MM, Baker J, Keefer L, Saps M, Cuff C, Hungria G, Videlock EJ, Chang L. Risk Factors for Abdominal Pain-Related Disorders of Gut-Brain Interaction in Adults and Children: A Systematic Review. Gastroenterology. 2022 Oct;163(4):995-1023.e3. doi: 10.1053/j.gastro.2022.06.028. Epub 2022 Jun 16.
PubMed 35716771Murray K, Wilkinson-Smith V, Hoad C, Costigan C, Cox E, Lam C, Marciani L, Gowland P, Spiller RC. Differential effects of FODMAPs (fermentable oligo-, di-, mono-saccharides and polyols) on small and large intestinal contents in healthy subjects shown by MRI. Am J Gastroenterol. 2014 Jan;109(1):110-9. doi: 10.1038/ajg.2013.386. Epub 2013 Nov 19.
PubMed 24247211Melchior C, Desprez C, Riachi G, Leroi AM, Dechelotte P, Achamrah N, Ducrotte P, Tavolacci MP, Gourcerol G. Anxiety and Depression Profile Is Associated With Eating Disorders in Patients With Irritable Bowel Syndrome. Front Psychiatry. 2020 Jan 8;10:928. doi: 10.3389/fpsyt.2019.00928. eCollection 2019.
PubMed 31969841MacIntosh A, Heenan PE, Wright-McNaughton M, Frampton C, Skidmore P, Wall CL, Muir J, Talley NJ, Roy NC, Gearry RB. The relationship between fermentable carbohydrates and post-prandial bowel symptoms in patients with functional bowel disorders. Front Nutr. 2023 Feb 2;10:1060928. doi: 10.3389/fnut.2023.1060928. eCollection 2023.
PubMed 36819701Jang SH, Choi SC, Kim YS, Ryu HS, Lee SY, Bahk WM. Psychological Characteristics and Quality of Life of Patients with Upper and Lower Functional Gastrointestinal Disorders. J Clin Med. 2022 Dec 23;12(1):124. doi: 10.3390/jcm12010124.
PubMed 36614925Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Ghoshal UC, Gwee KA, Chen M, Gong XR, Pratap N, Hou X, Syam AF, Abdullah M, Bak YT, Choi MG, Gonlachanvit S, Chua AS, Chong KM, Siah KT, Lu CL, Xiong L, Whitehead WE. Development, Translation and Validation of Enhanced Asian Rome III Questionnaires for Diagnosis of Functional Bowel Diseases in Major Asian Languages: A Rome Foundation-Asian Neurogastroenterology and Motility Association Working Team Report. J Neurogastroenterol Motil. 2015 Jan 1;21(1):83-92. doi: 10.5056/jnm14045.
PubMed 25537673Chuah KH, Beh KH, Mahamad Rappek NA, Mahadeva S. The epidemiology and quality of life of functional gastrointestinal disorders according to Rome III vs Rome IV criteria: A cross-sectional study in primary care. J Dig Dis. 2021 Mar;22(3):159-166. doi: 10.1111/1751-2980.12975.
PubMed 33595169Burton Murray H, Riddle M, Rao F, McCann B, Staller K, Heitkemper M, Zia J. Eating disorder symptoms, including avoidant/restrictive food intake disorder, in patients with disorders of gut-brain interaction. Neurogastroenterol Motil. 2022 Aug;34(8):e14258. doi: 10.1111/nmo.14258. Epub 2021 Oct 24.
PubMed 34693609Black CJ, Drossman DA, Talley NJ, Ruddy J, Ford AC. Functional gastrointestinal disorders: advances in understanding and management. Lancet. 2020 Nov 21;396(10263):1664-1674. doi: 10.1016/S0140-6736(20)32115-2. Epub 2020 Oct 10.
PubMed 33049221Biesiekierski JR, Rosella O, Rose R, Liels K, Barrett JS, Shepherd SJ, Gibson PR, Muir JG. Quantification of fructans, galacto-oligosacharides and other short-chain carbohydrates in processed grains and cereals. J Hum Nutr Diet. 2011 Apr;24(2):154-76. doi: 10.1111/j.1365-277X.2010.01139.x. Epub 2011 Feb 21.
PubMed 21332832Bellini M, Tonarelli S, Nagy AG, Pancetti A, Costa F, Ricchiuti A, de Bortoli N, Mosca M, Marchi S, Rossi A. Low FODMAP Diet: Evidence, Doubts, and Hopes. Nutrients. 2020 Jan 4;12(1):148. doi: 10.3390/nu12010148.
PubMed 31947991Barrett JS, Gearry RB, Muir JG, Irving PM, Rose R, Rosella O, Haines ML, Shepherd SJ, Gibson PR. Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther. 2010 Apr;31(8):874-82. doi: 10.1111/j.1365-2036.2010.04237.x. Epub 2010 Jan 22.
PubMed 20102355Atkins M, Zar-Kessler C, Madva EN, Staller K, Eddy KT, Thomas JJ, Kuo B, Burton Murray H. History of trying exclusion diets and association with avoidant/restrictive food intake disorder in neurogastroenterology patients: A retrospective chart review. Neurogastroenterol Motil. 2023 Mar;35(3):e14513. doi: 10.1111/nmo.14513. Epub 2023 Jan 4.
PubMed 36600490
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07000227
- Acronym / sponsor ID
- BRIDGE / JEP-2024-1144
- Conditions
- Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS), Functional Dyspepsia
- Keywords
- Functional Gastrointestinal Disorder, Irritable Bowel Syndrome, Functional Dyspepsia, FODMAP Restriction, Gentle FODMAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP diet | Active comparator | Behavioral: Low FODMAP dietLow FODMAP diet will be administered for two weeks |
| Gentle FODMAP diet | Active comparator | Behavioral: Gentle FODMAP dietGentle FODMAP diet will be administered for two weeks |
| Traditional Dietary Advice | Active comparator | Behavioral: Traditional Dietary AdviceTraditional Dietary advice will be administered for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low FODMAP dietHigh FODMAP foods are swapped for low FODMAP alternatives, for two weeks (Elimination phase) | Behavioural | Low FODMAP diet |
| Gentle FODMAP dietKey High FODMAP foods will be identified from patients' food diaries and swapped with low FODMAP alternatives. (Elimination phase) | Behavioural | Gentle FODMAP diet |
| Traditional Dietary AdviceSubjects 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 | Behavioural | Traditional Dietary Advice |
Primary outcome
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.
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
7 secondary outcomes
Effect of 2 week FODMAP restrictions on Symptom Severity (IBS-SSS questionnaire)
Time frame: 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)
Effect of 2-week FODMAP restriction on Quality of Life
Time frame: 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)
Effect of 2 week FODMAP restrictions on Anthropometry
Time frame: 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)
Effect of 2-week FODMAP restrictions on Symptom Severity (GSRS questionnaire)
Time frame: Measurement before (Day 1) and after the diet (Day 22)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 35716771Zia JK, Lenhart A, Yang PL, Heitkemper MM, Baker J, Keefer L, Saps M, Cuff C, Hungria G, Videlock EJ, Chang L. Risk Factors for Abdominal Pain-Related Disorders of Gut-Brain Interaction in Adults and Children: A Systematic Review. Gastroenterology. 2022 Oct;163(4):995-1023.e3. doi: 10.1053/j.gastro.2022.06.028. Epub 2022 Jun 16.
- Background: PubMed 24247211Murray K, Wilkinson-Smith V, Hoad C, Costigan C, Cox E, Lam C, Marciani L, Gowland P, Spiller RC. Differential effects of FODMAPs (fermentable oligo-, di-, mono-saccharides and polyols) on small and large intestinal contents in healthy subjects shown by MRI. Am J Gastroenterol. 2014 Jan;109(1):110-9. doi: 10.1038/ajg.2013.386. Epub 2013 Nov 19.
- Background: PubMed 31969841Melchior C, Desprez C, Riachi G, Leroi AM, Dechelotte P, Achamrah N, Ducrotte P, Tavolacci MP, Gourcerol G. Anxiety and Depression Profile Is Associated With Eating Disorders in Patients With Irritable Bowel Syndrome. Front Psychiatry. 2020 Jan 8;10:928. doi: 10.3389/fpsyt.2019.00928. eCollection 2019.
- Background: PubMed 36819701MacIntosh A, Heenan PE, Wright-McNaughton M, Frampton C, Skidmore P, Wall CL, Muir J, Talley NJ, Roy NC, Gearry RB. The relationship between fermentable carbohydrates and post-prandial bowel symptoms in patients with functional bowel disorders. Front Nutr. 2023 Feb 2;10:1060928. doi: 10.3389/fnut.2023.1060928. eCollection 2023.
- Background: PubMed 36614925Jang SH, Choi SC, Kim YS, Ryu HS, Lee SY, Bahk WM. Psychological Characteristics and Quality of Life of Patients with Upper and Lower Functional Gastrointestinal Disorders. J Clin Med. 2022 Dec 23;12(1):124. doi: 10.3390/jcm12010124.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 25537673Ghoshal UC, Gwee KA, Chen M, Gong XR, Pratap N, Hou X, Syam AF, Abdullah M, Bak YT, Choi MG, Gonlachanvit S, Chua AS, Chong KM, Siah KT, Lu CL, Xiong L, Whitehead WE. Development, Translation and Validation of Enhanced Asian Rome III Questionnaires for Diagnosis of Functional Bowel Diseases in Major Asian Languages: A Rome Foundation-Asian Neurogastroenterology and Motility Association Working Team Report. J Neurogastroenterol Motil. 2015 Jan 1;21(1):83-92. doi: 10.5056/jnm14045.
- Background: PubMed 33595169Chuah KH, Beh KH, Mahamad Rappek NA, Mahadeva S. The epidemiology and quality of life of functional gastrointestinal disorders according to Rome III vs Rome IV criteria: A cross-sectional study in primary care. J Dig Dis. 2021 Mar;22(3):159-166. doi: 10.1111/1751-2980.12975.
- Background: PubMed 34693609Burton Murray H, Riddle M, Rao F, McCann B, Staller K, Heitkemper M, Zia J. Eating disorder symptoms, including avoidant/restrictive food intake disorder, in patients with disorders of gut-brain interaction. Neurogastroenterol Motil. 2022 Aug;34(8):e14258. doi: 10.1111/nmo.14258. Epub 2021 Oct 24.
- Background: PubMed 33049221Black CJ, Drossman DA, Talley NJ, Ruddy J, Ford AC. Functional gastrointestinal disorders: advances in understanding and management. Lancet. 2020 Nov 21;396(10263):1664-1674. doi: 10.1016/S0140-6736(20)32115-2. Epub 2020 Oct 10.
- Background: PubMed 21332832Biesiekierski JR, Rosella O, Rose R, Liels K, Barrett JS, Shepherd SJ, Gibson PR, Muir JG. Quantification of fructans, galacto-oligosacharides and other short-chain carbohydrates in processed grains and cereals. J Hum Nutr Diet. 2011 Apr;24(2):154-76. doi: 10.1111/j.1365-277X.2010.01139.x. Epub 2011 Feb 21.
- Background: PubMed 31947991Bellini M, Tonarelli S, Nagy AG, Pancetti A, Costa F, Ricchiuti A, de Bortoli N, Mosca M, Marchi S, Rossi A. Low FODMAP Diet: Evidence, Doubts, and Hopes. Nutrients. 2020 Jan 4;12(1):148. doi: 10.3390/nu12010148.
- Individual participant dataSharing planned: No. We will not be sharing individual patient data to the trial registry to protect participant confidentiality, as institutional policies restrict such disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neoh Hui-Min, Assc. Prf study chair
National University of Malaysia
Vanitha Mariappan, Dr study chair
National University of Malaysia
Deborah Chia Hsin Chew, Dr study chair
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice in people with Functional Gastrointestinal Disorders (FGIDs) and Irritable Bowel Syndrome (IBS), run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanthi Krishnasamy, Dr (+60182017116, shanthikrishnasamy@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity (time frame: Measurement before (Day 1) and after the diet (Day 22)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000227, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.