FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Negativation of digestive tract colonization
研究概览
简要总结
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.
详细描述
Main objective:
Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.
Secondary objectives:
English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient harboring a VRE or CRE bacteria
- •Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month
排除标准
- •Pregnant woman or breastfeeding
- •immunosuppression including AIDS, corticosteroids over 60mg/day
- •ongoing antibiotic treatment at the day of inclusion
- •impossibility to obtain a signed consent form.
研究组 & 干预措施
Fecal transplantation
Patient will be transplanted with a healthy donor microbiota, free from XDR bacteria, in order to evaluate the impact on the digestive tract colonization Whole process of feces screening and reconstitution was under the responsibility of the pharmacists in charge of the study.
Patient will benefit of a naso-duodenal tube in order to perform a bowel lavage prio to the fecal microbiota transplant.
Patient will be monitored for 24h to rule out potential adverse events.
干预措施: fecal microbiota transplant (Drug)
结局指标
主要结局
Negativation of digestive tract colonization
时间窗: At one week, 2 weeks, one month up to 6 months
Negativation of the rectal swab performed, free from CRE or GRE
次要结局
- Metagenomics profile between donor and recipient depending on decolonization(At one week, 2 weeks, one month up to 3 months)
研究者
Benjamin DAVIDO
M.D, M.S
Centre d'Investigation Clinique et Technologique 805