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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score. [Срок оценки: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):]

Вторичные конечные точки (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales [Срок оценки: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
• Gastrointestinal symptom evaluation [Срок оценки: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
• IBS- quality of life (IBS-QOL) [Срок оценки: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT07543354 · 2025-05-001CC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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