About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult (age≥18 years) patients listed for OLT for various etiologies.
Patient's consent to participate in the study
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Fecal microbiota transplantation (FMT)
Procedure/SurgeryTo assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
Treatment groups
Trial outcomes
Primary outcomes
To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
Incidence of clinically severe infections (sepsis, severe sepsis, septic shock)
Secondary outcomes
Incidence of adverse events after FMT
To evaluate the safety profile of both heterologous and autologous FMT in patients enlisted for OLT and the relationship between fecal microbiota composition and the gastrointestinal permeability profile before and after FMT.
Sponsors and contacts
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