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NCT Number: NCT06782880

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

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.

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Key information

Conditions

Fecal Microbiota Transplantation Multi-drug Resistant Bacteria Orthotopic Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Giovanni Barbara, MD

CONTACT

[email protected]

+390512144103

Giovanni Barbara, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fecal microbiota transplantation (FMT)

Procedure

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 outcomes

  1. 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

    Incidence of clinically severe infections (sepsis, severe sepsis, septic shock)

Secondary outcomes

  1. Incidence of adverse events after FMT

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Barbara, MD

CONTACT

[email protected]

+390512144103

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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