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Recruiting NCT06782880

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

No phase Interventional Fecal Microbiota Transplantation Orthotopic Liver Transplantation Multi-drug Resistant Bacteria

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbiota transplantation (FMT).
Who it may be relevant to
Registry conditions: Fecal Microbiota Transplantation, Orthotopic Liver Transplantation, Multi-drug Resistant Bacteria. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation

Overview

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.

Detailed 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.

Interventions

  • Procedure Fecal microbiota transplantation (FMT)
    To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.

Primary outcome measures

  • To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT. [Time frame: At 6 months after OLT]
Secondary outcome measures (1)
  • Incidence of adverse events after FMT [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Identifiers

NCT: NCT06782880 · FMT-OLT · Bando RF-2021-12373311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗