NCT01774825已完成3 期
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-CL-101 in the Symptomatic Improvement of Irritable Bowel Syndrome (IBS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- IBS-SSS (Severity Symptom Score)
研究概览
简要总结
After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfils Rome-III criteria for IBS diagnosis
- •Females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential
- •Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
排除标准
- •Known sensitivity to any of the ingredients of IQP-CL-101
- •Clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization
- •Other causes of IBS symptoms such as inflammatory bowel disease (IBD), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding
- •Use of medications that could influence GI functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization
- •Clinically relevant excursions of safety parameters
- •Any other conditions deemed relevant by the investigator(s)
结局指标
主要结局
IBS-SSS (Severity Symptom Score)
时间窗: 8 weeks
The questionnaire is to be completed by the subject
次要结局
- Efficacy assessment by subject(8 weeks)
- Safety assessment by subject(8 weeks)
- IBS-QOL (Quality of Life)(8 weeks)
- Efficacy assessment by investigator(8 weeks)
- Blood pressure(8 weeks)
- Adverse events(8 weeks)
- Pain and discomfort diary(8 weeks)
- Clinical chemistry(8 weeks)
- Safety assessment by investigator(8 weeks)
- Fecal calprotectin(8 weeks)
- IBS-GIS (Global Improvement Score)(8 weeks)
- Full blood count(8 weeks)
研究者
研究点 (2)
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