Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Stool sample C. diff toxin assay
研究概览
简要总结
The purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.
详细描述
Clostridium difficile associated disease (CDAD), which nearly always follows antibiotic therapy, has become increasingly common and important in American hospitals, causing substantial morbidity and mortality. Metronidazole is the recommended treatment for this condition. We have recently reported (Clin Infect Dis, June 2005) that treatment with metronidazole is associated with a 22% rate of failure and 28% rate of relapse. No other medication has been shown to be more effective. There is a substantial theory and some limited data to suggest that dietary supplementation with non-pathogenic normal bowel bacteria will benefit these patients. Lactobacillus GG is the best-standardized and the most extensively studied of these agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin
排除标准
- •Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded.
- •Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus.
研究组 & 干预措施
Arm 2
This arm will receive lactobacillus
干预措施: Lactobacillus GG (Drug)
结局指标
主要结局
Stool sample C. diff toxin assay
时间窗: 30 days after start of medication
presence of C. diff toxin in stool after 30 days
Response to Treatment
时间窗: less than 10 days
the time to resolution of diarrhea caused by diarrhea
次要结局
未报告次要终点
研究者
Daniel M. Musher MD
Principle Investigator
Michael E. DeBakey VA Medical Center
