Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A negative stool culture for Carbapenem resistant Klebsiella pneumonia.
研究概览
简要总结
Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will decrease the rate of GI colonization by CRKP.
详细描述
CRKP colonization will be determined by culture and PCR of rectal swabs. The study will include 3 arms - no intervention, probiotics and mechanical bowel cleansing + probiotics. Followup examination of rectal swab samples for the presence of CRKP will be performed at 4 weeks and 12 weeks from study entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 who are > 18 years of age.
- •Signing of informed consent by subject or legal custodian.
- •Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
- •Negative cultures for CRKP from extra-intestinal sites excluding urine.
排除标准
- •Subjects who have participated in another clinical trial within the last three months.
- •Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
- •Subjects who are pregnant or breast feeding.
- •Subjects who will be unavailable for the duration of the trial, are likely to be non-compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
- •Subjects with chronic diarrhea (>4 weeks).
- •Subjects with inflammatory bowel disease.
- •Subjects whose stool is positive for Clostridium difficile toxin.
- •Subjects receiving immunosuppressive treatment (i.e. corticosteroids; azathioprine or 6-MP; cyclosporine; tacrolimus; OKT3, methotrexate; anti TNF agents; chemotherapy).
- •Subjects who underwent solid organ or hematopoietic stem cell transplantation.
- •Subjects with primary or secondary immunodeficiency disorders, including HIV.
- •Subjects with chronic advanced cardiac, respiratory, renal or liver disease.
- •Subjects with advanced malignant disease.
- •Subjects with severe acute organ failure.
- •Subjects in whom CRKP is isolated from sites other than stool or urine (i.e. blood, sputum or wound cultures).
研究组 & 干预措施
B
VSL#3 for 4 weeks
干预措施: VSL#3 (Dietary Supplement)
C
Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
干预措施: VSL#3 (Dietary Supplement)
C
Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
干预措施: Polyethylene glycol (Drug)
结局指标
主要结局
A negative stool culture for Carbapenem resistant Klebsiella pneumonia.
时间窗: 4 weeks.
次要结局
- A negative stool culture and/or PCR assay for CRKP at twelve weeks after initiation of probiotics (i.e - 8 weeks after cessation of probiotic treatment).(12 weeks beginning of intervention.)