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

NCT07543354 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

BEHAVIORAL

AI-assisted Mobile Application for Low-FODMAP Diet

Participants in this group will receive a specialized AI-assisted mobile application (LFDapp) to manage their diet. The app provides real-time guidance, meal suggestions, and tracking tools to help clinicians and dietitians establish a personalized low-FODMAP dietary treatment plan. Participants will follow the diet for an initial 4-6 weeks, followed by a reintroduction and personalization phase.

BEHAVIORAL

LFD booklet group

Participants in this group will receive dietary education using printed LFD booklets. The booklet includes dietary guidelines, food lists (high vs. low FODMAP), and sample meal plans provided by a dietitian. Participants will follow the same intervention timeline (initial 4-6 weeks, reintroduction, and personalization) as the app group but without mobile app support.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-06-30
Completion
2029-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543354 on ClinicalTrials.gov