NCT02721836已完成不适用
Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Irritable Bowel Syndrome Symptoms
研究概览
简要总结
The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to nutrition counselling. Further, the potential of both interventions to influence the gut microbiome will be inquired.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria
排除标准
- •inflammatory bowel diseases (IBD)
- •total abdominal colectomy
- •no sonographie or colonoscopy as diagnostic criterion
- •stool lactoferrin > 7mg/g
- •pregnancy or breast feeding
- •simultaneous participation in further clinical intervention trials
- •Regular yoga practice or nutrition counselling in the past 12 months
- •Planned surgery in the study period
- •Serious illness that would interfere with the ability to practice yoga
结局指标
主要结局
Irritable Bowel Syndrome Symptoms
时间窗: Week 12
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
次要结局
- Emotional distress(Week 24)
- Subjective improvement of symptoms(Week 24)
- Irritable Bowel Syndrome Symptoms(Week 24)
- Subjective Stress(Week 24)
- disease specific quality of life(Week 24)
- Generic Health-related Quality of life(Week 24)
- Gut microbiome(Week 12)
- Adverse Event(Week 24)
研究者
Dania Schumann
Principal Investigator, Research fellow
Universität Duisburg-Essen
研究点 (2)
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