Comparative Effects of Low-FODMAP and Lactose-Gluten-Free Diets on Gastrointestinal Symptoms and Mental Health in Irritable Bowel Syndrome: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder that substantially affects quality of life. Dietary therapy is considered one of the primary treatment approaches; however, the optimal sequence of dietary interventions remains unclear. This randomized crossover trial was designed to compare the effects of a low-FODMAP diet and a lactose-free, gluten-free diet on gastrointestinal symptoms, psychological status, anthropometric measurements, and biochemical parameters in adults with IBS. Participants were randomly assigned to one of two dietary sequences, with each intervention lasting four weeks and separated by a one-week washout period. Outcomes were assessed using validated symptom and psychological questionnaires together with anthropometric and biochemical measurements before and after each intervention period.
详细描述
This randomized crossover trial was designed to evaluate the comparative effects of a low-FODMAP diet and a lactose- and gluten-free diet in adults with irritable bowel syndrome (IBS). Participants were randomly assigned to one of two dietary sequences, with each intervention lasting 4 weeks and separated by a 1-week washout period. Gastrointestinal symptoms, psychological outcomes, anthropometric measurements, and biochemical parameters were assessed before and after each intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-64 years.
- •Diagnosis of Irritable Bowel Syndrome according to the Rome III criteria.
- •Ability and willingness to comply with the dietary intervention.
- •Written informed consent provided.
排除标准
- •Pregnancy or lactation.
- •Diabetes mellitus.
- •Organic gastrointestinal disease.
- •Current follow-up for cardiologic, neurologic, oncologic, or psychiatric disorders.
- •Following a therapeutic diet within 1 month before enrollment.
结局指标
主要结局
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
时间窗: Baseline, Week 4, and Week 9
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). The IBS Symptom Severity Score assessed the severity of IBS symptoms based on four questions, scoring between 0 and 100 points for each symptom. A total score of 75-174 points indicated mild IBS, 175-299 points indicated moderate IBS, and \>300 points indicated severe IBS.
次要结局
- Change in Gastrointestinal Symptom Rating Scale (GSRS) score(Baseline, Week 4, and Week 9)
- Change in Hospital Anxiety and Depression Scale (HADS) score(Baseline, Week 4, and Week 9)
- Change in body weight(Baseline, Week 4, and Week 9)
- Change in body mass index(Baseline, Week 4, and Week 9)