Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Proportion of hospitalizations attributable to FMT
研究概览
简要总结
Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. Recurrent forms are a major problem with this infection. The use of fecal microbiota transplantation (FMT), FMT appears in the most recent European and North American recommendations.
There is no cohort or multicenter registry in France prospectively collecting FMTs, the methods used, their efficacy and side effects. Likewise, there is no prospective collection focused on the cohort of stool donors. A large national cohort of patients who have undergone FMT as part of routine care as well as donors, is essential for evaluating the safety of FMT.
详细描述
Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. For 20 years, the incidence of CDI has continued to increase. In addition, the severity of infections is also increasing (mortality: 5% in 1990 against 13.8% in 2003; complications: 6% in 1990 against 18% in 2003).
Recurrent forms represent a major problem of this infection. Indeed, after a first episode, the risk of a first recurrence is around 15 to 25% and this risk then increases with each recurrence, reaching 45% then 65% after a first and second recurrence respectively. These Recurrent forms pose a real therapeutic problem, causing significant morbidity (repeated hospitalizations, time off work, etc.) and substantial mortality. Patients with CDI are 2.5 times more likely to die within 30 days of infection than uninfected patients, regardless of age or comorbidities. The mortality rate is also higher in patients with a recurrent form than in those with a single episode. Furthermore, the antibiotics usually used are only marginally effective in cases of recurrent CDI.
Numerous studies, including two randomized trials, have shown that fecal microbiota transplantation (FMT), is superior to antibiotic therapy in reducing subsequent recurrences, the use of FMT in this indication appears in the most recent European and North American recommendations.
Cosmic-FMT cohort aims to be as representative as possible of the population of patients having FMT for CDI in the context of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI);
- •Informed written consent
- •Adult (18 years or older)
- •Informed Written consent
排除标准
- •insufficient level of understanding of written and spoken French language
结局指标
主要结局
Proportion of hospitalizations attributable to FMT
时间窗: Week 10 and 3 years after FMT
次要结局
- Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors(at 10 weeks and 3 years)
- adverse event rate(24hours, 10weeks, every 6 months until 3 years)
- Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10).(Day 0 and Week 10)
- Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients(at 10 weeks and 3 years)
- Proportion of relapse(Week 10 and 3 years)
- Patient status (absence of recurrence or relapse or re-infection) according to the composition of the microbiota (by sequencing or metabolomic method or culture) of the donors.(Week 10)
- Composition of the patient's microbiota before FMT and at week 10 and composition of the donor's microbiota (by sequencing or metabolomic method or culture) of the raw stool and the preparation to be administered to the patient.(before FMT and at week 10 for patients)
- Proportion of Clostridium difficile relapses(10 weeks after FMT, and 3 years)
- Proportion of reinfections(Week 10 and 3 years)
- Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to the method of preparation and administration of fecal preparation(at 10 weeks and 3 years)
- Evolution of transit (i.e. number of stools per day and their consistency) and mean BMI in patients Correlation between the evolution of transit and the BMI of the donor and the patient.(Before and after FMT at Week 10, at Month 6 then every 6 months until Month 36)