Clinical Trial

Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis

Not Yet Recruiting
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Summary
The purpose of this study is to evaluate the effectiveness of a mobile application (app) in helping clinicians and dietitians provide personalized low-FODMAP diet (LFD) therapy for patients with Irritable Bowel Syndrome (IBS). The study also aims to explore the potential biological mechanisms behind the clinical outcomes of this dietary intervention. Participants diagnosed with IBS will be recruited and screened through clinical questionnaires. Eligible participants will receive dietary education from a dietitian and be randomly assigned to one of two groups: the AI-assisted LFDapp group or the LFD booklet group. The study consists of three main phases: Initial Intervention (4-6 weeks): Participants will follow their assigned diet intervention and complete assessments regarding gastrointestinal symptoms, psychological traits (such as anxiety and depression), and quality of life. Reintroduction Phase (12 weeks): Participants who respond well to the diet will enter a phase where specific foods are gradually reintroduced. Personalization \& Follow-up (4 weeks): A personalized diet will be established, followed by a final evaluation of bowel function and mental well-being. Researchers will use various standardized questionnaire to track changes in symptoms and overall well-being throughout the study period.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-14.
Trial Details
NCT Number NCT07543354
Lead Sponsor Taipei Veterans General Hospital, Taiwan
Conditions IBS - Irritable Bowel Syndrome
Enrollment 200 participants
Start Date 2026-04
Primary Completion 2028-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-15