Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
研究概览
简要总结
The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.
详细描述
The study is a double-blind, single-center, randomized controlled trial and will be offered consecutively to every adult patient on the liver transplant list.
Enrolled patients will be randomized (1:1) and assigned to either the heterologous or autologous fecal microbiota transplantation.
The intervention of the trial is heterologous fecal microbiota transplantation, which involves the administration of fecal material from a healthy donor into the intestine of the enrolled patient. Fecal samples will be collected every three months and before each microbiota transplant for evaluation of fecal microbiota composition. Gut permeability tests will be evaluated at enrollment and after the first fecal transplantation. Moreover, clinical and microbiota assessments will be performed after liver transplantation. All other planned assessments are part of the normal course of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (age≥18 years) patients listed for OLT for various etiologies.
- •Patient's consent to participate in the study
排除标准
- •Previous total colectomy
- •Pregnancy or breastfeeding
- •Patients on oral or intravenous antimicrobial agents
- •HIV positive and not well controlled on antiretroviral therapy, or CD4+ <200/ mm3
- •Active SARS-CoV-2 infection
- •Neutropenia <0.5X10^9/L
- •Toxic megacolon
- •Contraindications to colonoscopy
- •Any conditions for which, according to the physician, FMT endangers the patient's health
- •History of hypersensitivity to macrogol contained in bowel preparations.
研究组 & 干预措施
Heterologous FMT
Heterologous feces will be processed from routinely screened universal donors. Adult patients listed or being evaluated for enlistment for OLT for various etiologies are eligible for Fecal Microbiota Transplantation. Fecal material must be infused by enema or colonoscopy.
干预措施: Fecal microbiota transplantation (FMT) (Procedure)
Homologous FMT
The control arm will undergo autologous FMT after enrollment. Autologous feces will be collected by each patient the day before each FMT in both study arms. This will guarantee adequate patients' stool collection in order to subsequently store the fecal samples for autologous FMT and ensure blinding.
干预措施: Fecal microbiota transplantation (FMT) (Procedure)
结局指标
主要结局
To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
时间窗: At 6 months after OLT
Incidence of clinically severe infections (sepsis, severe sepsis, septic shock)
次要结局
- Incidence of adverse events after FMT(3 years)