Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Multi-drug Resistant Bacteria; Orthotopic Liver Transplantation; Fecal Microbiota Transplantation

Treatments: Procedure: Fecal microbiota transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06782880

FMT-OLT

Bando RF-2021-12373311 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult (age≥18 years) patients listed for OLT for various etiologies.
• Patient's consent to participate in the study

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Heterologous FMT

Experimental group

Description:

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.

Treatment:

Procedure: Fecal microbiota transplantation (FMT)

Homologous FMT

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Fecal microbiota transplantation (FMT)