NCT01491659撤回4 期
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Occurence of Antibiotic Associated Diarrhea
研究概览
简要总结
It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
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
- Triple (Participant, Care Provider, 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
- •Healthy volunteers 18-70 years of age
- •Subjects with normal gastrointestinal function
- •Subjects willing to provide written informed consent
排除标准
- •Subjects receiving antibiotic treatment within three months prior to inclusion in the study
- •Pregnancy or planned pregnancy
- •Breast feeding
- •Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components
- •Subjects with known renal insufficiency
- •Subjects using products containing probiotics, fibers and/or prebiotics
- •Subjects using proton pump inhibitors
- •Subjects using H2 antagonists
- •Subjects using antacids frequently
结局指标
主要结局
Occurence of Antibiotic Associated Diarrhea
时间窗: 17 days
次要结局
- Duration of Antibiotic Associated Diarrhoea(17 days)
- Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day(17 days)
- Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom(17 days)
- Changes in the Gut Microbiota Composition(17 days)
- Changes in Markers of Antibiotic Resistance(17 days)
研究者
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