NCT01202630暂停3 期
A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Incidence of recurrent Clostridium difficile infection
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
- •Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
- •Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- •Understand the nature and purpose of the study including potential risks and side effects
- •Willing to comply with the requirements of the study
排除标准
- •History of 2 or more clostridium difficile infections at any time prior to the current episode
- •Presence of severe chronic and/or inflammatory condition
- •Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
- •Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- •Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- •Use of proton pump inhibitors
- •Pregnant female or breastfeeding
- •Eating disorder
- •History of alcohol, drug, or medication abuse
- •Daily consumption of probiotics, fermented milk, and/or yogurt
- •Known allergies to any substance in the study product
- •Participation in another study with any investigational product within 3 months of screening
结局指标
主要结局
Incidence of recurrent Clostridium difficile infection
时间窗: 60 days
次要结局
- Presence of gastrointestinal symptoms(60 days)
- Duration of recurrent diarrhea episodes(60 days)
- Adverse events(60 days)
研究者
研究点 (2)
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