Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Randomly assigned in a 1:1 ratio to either the LFD app or LFD booklet group using a computer-generated random number table. The randomization sequence was sealed in opaque sealed envelopes, opened just before meeting the patients
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AI-assisted LFDapp group
Participants receive low-FODMAP diet education supported by a dedicated AI-assisted mobile application.
干预措施: AI-assisted Mobile Application for Low-FODMAP Diet (Behavioral)
LFD booklet group
Participants receive low-FODMAP diet education using traditional printed educational booklets.
干预措施: LFD booklet group (Behavioral)
结局指标
主要结局
Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score.
时间窗: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):
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).
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales(Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks))
- Gastrointestinal symptom evaluation(Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks))
- IBS- quality of life (IBS-QOL)(Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks))
- Hospital Anxiety and Depression Scale (HADS)(Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks))