IBS Low-FODMAP Diet Mobile App Randomized Trial: AI-App vs Dietary Booklet
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registers a randomized controlled trial (NCT07543354) evaluating an AI-assisted mobile application against a standard low-FODMAP diet (LFD) booklet for treating Irritable Bowel Syndrome (IBS). The three-phase study spans approximately 20 weeks and will track gastrointestinal symptoms, psychological traits, and quality of life outcomes across both intervention arms.
What changed
This ClinicalTrials.gov registry entry documents a randomized controlled trial comparing an AI-assisted mobile application with a traditional low-FODMAP diet booklet for IBS management. The study enrolls adults diagnosed with IBS, provides dietary education through dietitians, and randomizes participants to either the AI-app or booklet arm over three phases: initial intervention (4-6 weeks), reintroduction (12 weeks), and personalization follow-up (4 weeks).
Healthcare providers offering dietary therapy for IBS, and companies developing digital health applications for gastrointestinal conditions, may want to monitor the outcomes of this trial. Positive findings could inform future clinical guidelines for app-based dietary interventions in functional GI disorders.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis
N/A NCT07543354 Kind: NA Apr 21, 2026
Abstract
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: AI-assisted Mobile Application for Low-FODMAP Diet, LFD booklet group
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