NCT00747071撤回2 期
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Recurrence of active Clostridium difficile associated diarrhea in index cases
研究概览
简要总结
This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 or older
- •Written informed consent
- •At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
- •Confirmed diagnosis of C. difficile associated diarrhea
排除标准
- •Pregnant or breast feeding women
- •Known allergy to milk or milk products
- •Other etiology of diarrhea
- •Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
- •Pseudomembranous colitis
- •White blood count > 50,000
- •Blood in stools
- •Laxatives or motility drugs within 12 hours
- •Inability to participate in adequate follow up
- •Clinically unstable
- •Investigator deems unsuitable
- •Immune suppression (disease or treatment)
- •GI surgery
- •Past intestinal parasites
研究组 & 干预措施
1
Experimental
Hospitalized patients with Clostridium difficile associated diarrhea.
干预措施: Colostrum (Drug)
2
Experimental
Close hospital contacts of each index case
干预措施: Colostrum (Drug)
结局指标
主要结局
Recurrence of active Clostridium difficile associated diarrhea in index cases
时间窗: 60 days
New cases of Clostridium difficile associated diarrhea in close hospital contacts.
时间窗: 60 days
次要结局
- Disease severity - duration, maximal intensity (number of stools) in index cases.(60 days)
- Eradication of Clostridium difficile from stools(1 year)
研究者
研究点 (1)
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