Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-assisted Mobile Application for Low-FODMAP Diet, LFD booklet group.
- Who it may be relevant to
- Registry conditions: IBS - Irritable Bowel Syndrome. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score. [Time frame: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):]
Secondary outcome measures (4)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales [Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
- Gastrointestinal symptom evaluation [Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
- IBS- quality of life (IBS-QOL) [Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- History of thyroid disease.
- Major psychiatric disorders, including patients with significant anxiety or depression currently requiring treatment with anti-anxiety or anti-depressant medications.
- History of epilepsy.
- History of stroke, cerebral hemorrhage, or other central nervous system diseases.
- Significant renal, hepatic, or major cardiovascular diseases.
- Malignant diseases (cancer).
- Type 2 diabetes.
- Other chronic pain conditions.
- History of abdominal surgery (excluding cholecystectomy or appendectomy) or any history of brain surgery.
- Appendectomy or cholecystectomy performed within the past year.
- Currently participating in other clinical trials.
- Use of antibiotics or analgesics within 90 days prior to enrollment.
- Newly initiated use of probiotics or prebiotics within 90 days prior to enrollment.
- Current use of antipsychotic medications, antidiarrheal agents, probiotics, or analgesics.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07543354 · 2025-05-001CC