NCT01243853Unknown不适用
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
Verman Oy Ab2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- IBS symptom severity
研究概览
简要总结
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of IBS according to Rome III criteria, additionally abdominal distension or flatulence the most disturbing symptom
- •Age 18-65 years
- •Colonoscopy conducted within the previous 5 years, finding macroscopically and histologically normal
排除标准
- •Organic GI disease. Treated (min. 1 year) coeliac disease patients, and subjects with known and treated lactose intolerance are allowed to participate
- •Malignancy
- •Significant gastrointestinal surgery
- •Clinically significant aberrancies in the screening-phase laboratory analyses
- •Changes in regular medication during the previous 4 weeks
- •Pregnancy or breast feeding
- •Other disease or state that based on the investigator's evaluation complicates the conduction of the intervention, i.e. alcoholism, dementia
- •Hereditary galactosemia
结局指标
主要结局
IBS symptom severity
时间窗: follow-up (4 months)
The IBS symptom severity score (IBS-SSS) questionnaire is used
次要结局
未报告次要终点
研究者
研究点 (2)
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