跳至主要内容
临床试验/NCT00304863
NCT00304863撤回4 期

Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease

Michael E. DeBakey VA Medical Center1 个研究点 分布在 1 个国家开始时间: 2008年8月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Daniel M. Musher MD

Principle Investigator

Michael E. DeBakey VA Medical Center

研究点 (1)

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