An interventional study of AI-assisted Mobile Application for Low-FODMAP Diet and LFD booklet group in IBS - Irritable Bowel Syndrome, sponsored by Taipei Veterans General Hospital, Taiwan. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 200 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive low-FODMAP diet education supported by a dedicated AI-assisted mobile application.
Behavioral: AI-assisted Mobile Application for Low-FODMAP Diet
Participants receive low-FODMAP diet education using traditional printed educational booklets.
Behavioral: LFD booklet group
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.
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.
Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score.
The IBS-SSS is a validated scale used to assess the severity of IBS symptoms. It consists of five items: abdominal pain severity, abdominal pain frequency, abdominal distension/bloating, dissatisfaction with bowel habits, and interference with life. Each item is scored from 0 to 100, for a total possible score of 500. Higher scores indicate more severe symptoms. (A decrease in score represents clinical improvement).
Time frame: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):
Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales
A standardized 5-item, patient-reported tool used to measure the frequency and severity of abdominal pain or discomfort over a 7-day period. The total score ranges from 5 to 25, where higher scores indicate greater symptom severity (a worse outcome).
Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Gastrointestinal symptom evaluation
To evaluate the current gastrointestinal symptom status, the gastrointestinal symptom rating scale (GSRS) will be used. GSRS is an interview-based 7-likert rating scale consisting of 15 items for assessment of gastrointestinal symptoms for irritable bowel syndrome and peptic ulcer disease.The total score ranges from 15 to 105, with higher scores representing more severe symptoms (a worse outcome).
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)
IBS-QOL is a validated condition-specific QOL measure for IBS.29 It contains of 34 items focusing on different conditions including dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual and relationship. IBS-QOL has been used to evaluate the overall health related QOL influenced by IBS.Each item is scored on a 5-point scale, and the total raw score is transformed to a 0-100 scale. Higher scores indicate better health-related quality of life (a better outcome).
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)
HADS is a simple developed scale used by doctors to evaluate anxiety and depression condition of a patient. It is often used to evaluate patients with different diseases, such as psychiatric, cancer, chronic pain or handicapped to evaluate about their emotional condition. Each subscale score ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression (a worse outcome).It had been translated in Chinese version and used in many previous studies.
Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Plan to share: No
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Taipei Veterans General Hospital, Taiwan