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Mechanism of FODMAP Restriction on FGID Patients

Study acronym: BRIDGE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion date changed from estimate of Jun 30, 2026 to Sep 24, 2026 Show 5 more changesShow less
    • Study completion pushed from Sep 30, 2026 to Oct 30, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Publications: details revised at 14 of 14 entries
    • Study description expanded, about 3 words
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 20, 2025 to Jul 20, 2025
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07000227
Lead Sponsor Universiti Kebangsaan Malaysia Medical Centre
Conditions
(from sponsor)
Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS), Functional Dyspepsia
Related terms Gastrointestinal Diseases, Irritable Bowel Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov