EUCTR2015-000868-34-DE进行中（未招募）1 期
Randomized, placebo controlled phase III trial of a microbiological concomitant therapy/prevention of chemotherapeutical induced diarrhea (caused by inflammation and an impaired intestinal barrier) with E. coli Nissle 1917 (EcN)-Suspension in patients with gastric and colorectal cancer - E. coli Nissle in oncology (EcNO-study)
ZKES GmbH0 个研究点开始时间: 2015年4月9日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female adults; patients with gastric or colorectal cancer (stages III or IV), where a treatment with 5-Fluoruracil and one further chemotherapeutical remedy (either Irinoecan or a platinum based chemotherapeutical remedy) is planned, the addition of bevacizumab antibody is allowed as well; life expectancy of at least the trial duration; the first administering of the product under investigation must be able to take place 72 hours befor or after the beginning of the chemotherapeutical treatment, ideally at the same time; an inclusion into the study is only possible at the beginning of the first chemotherapeutic cycle; fertile female patients (aged 49 years or minor, the last menstruation occured in less than two years) have to be either surgically sterilized or use the same highly effective method of contraception for at least three minths; willingness to refrain from other probiotics or probiotic yoghurts, a systematic change of eating behavior should not be planned; sufficient knowledge of german language and sufficient psychological state for being able to answer questionnaires and assessment scales; informed written consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •Participation in other clinical trials (currently or within the last 30 days); intolerance against ingredients of the product under investigation; pregnancy or lactation; beeing not able to consume the product under investigation orally; antidiarrheal therapy with antibiotics; alcohol or drug abuse within the last six months; any health condition (including abnormal blood parameters) which refuses a patient from taking part in the study according to the opinion of the investigator
研究者
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