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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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.

Eligibility criteria

Qualifiers

Participants aged between 20 and 65 years.

Diagnosed with Irritable Bowel Syndrome (IBS)

Overall IBS symptoms remain unresolved or active at the time of enrollment.

Disqualifiers

Inability to understand the study procedures or provide written informed consent.

Currently pregnant.

History of Inflammatory Bowel Disease (IBD).

Active infection within the past 90 days.

Trial design

Treatments tested in this trial

  • AI-assisted Mobile Application for Low-FODMAP Diet
  • LFD booklet group

Treatment groups

200 Participants
are divided into 2 treatment groups