Mechanism of FODMAP Restriction on FGID Patients

NCT07000227 | Recruiting

• 2 other identifiers: JEP-2024-1144FRGS/1/2023/SKK06/UKM/03/4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Functional Gastrointestinal Disorder; Irritable Bowel Syndrome; Functional Dyspepsia; FODMAP Restriction; Gentle FODMAP

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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)

  Measurement before (Day 1) and after the diet (Day 22)

• Effect of 2-week FODMAP restriction on Psychological Status

  Measurement before (Day 1) and after the diet (Day 22)

• Effect of 2-week FODMAP restriction on Quality of Life

  Measurement before (Day 1) and after the diet (Day 22)

• Effect of 2-week FODMAP restriction on Food Avoidance

  Measurement before (Day 1) and after the diet (Day 22)

• Effect of 2 week FODMAP restrictions on Anthropometry

  Measurement before (Day 1) and after the diet (Day 22)

Study Arms (3)

Low FODMAP diet

ACTIVE COMPARATOR

Low FODMAP diet will be administered for two weeks

Behavioral: Low FODMAP diet

Gentle FODMAP diet

ACTIVE COMPARATOR

Gentle FODMAP diet will be administered for two weeks

Behavioral: Gentle FODMAP diet

Traditional Dietary Advice

ACTIVE COMPARATOR

Traditional Dietary advice will be administered for two weeks

Behavioral: Traditional Dietary Advice

Interventions

Low FODMAP diet BEHAVIORAL

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

Low FODMAP diet

Gentle FODMAP diet BEHAVIORAL

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

Gentle FODMAP diet

Traditional Dietary Advice BEHAVIORAL

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

Traditional Dietary Advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (14)

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  PMID: 35716771 BACKGROUND

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  PMID: 31969841 BACKGROUND

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  PMID: 36819701 BACKGROUND

• Jang 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.

  PMID: 36614925 BACKGROUND

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• Burton 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.

  PMID: 34693609 BACKGROUND

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  PMID: 31947991 BACKGROUND

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  PMID: 36600490 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• 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 CHAIR

• Jaysrina Mahalinga Moorthy, Ms

  National University of Malaysia

  STUDY DIRECTOR

Central Study Contacts

Shanthi Krishnasamy, Dr

CONTACT

+60182017116; shanthikrishnasamy@ukm.edu.my

Jaysrina Mahalinga Moorthy

CONTACT

+60138372089; P153921@siswa.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 2, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)