Using fecal microbiota transplantation to prevent infections after liver transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of heterologous fecal microbiota transplantation (FMT) to reduce the risk of multi-drug resistant bacteria (MDRB) infections in patients undergoing orthotopic liver transplantation (OLT). It is a double-blind, single-center, randomized controlled trial where adult patients on the liver transplant list will be randomly assigned to receive either FMT from a healthy donor or their own fecal material. The study will assess the composition of fecal microbiota and gut permeability before and after the transplantation process, along with clinical evaluations post-surgery. The goal is to determine if FMT can effectively decolonize MDRB and restore a healthier gut microbiome in these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Giovanni Barbara, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Giovanni Barbara, MD
• Email: giovanni.barbara@unibo.it
• Phone: +390512144103

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fecal transplant plus standard therapy for refractory hepatic encephalopathy after TIPS

  This study tests whether adding fecal microbiota transplantation to usual medicines helps people with recurrent hepatic encephalopathy after TIPS implant.

  Recruiting Early Phase 1 Air Force Military Medical University, China · Xi'an · NCT07683936

• Identifying factors influencing alcohol relapse in liver transplant patients

  This study looks at what causes some liver transplant patients, who struggled with alcohol problems before, to relapse into drinking again after their surgery.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT06749990

• Maternal fecal transplant for babies born by cesarean section

  This trial will try giving a small fecal transplant from the mother to newborns delivered by elective C-section to see if it improves their gut microbiome and lowers the risk of later overweight or obesity.

  Recruiting Oulu University Hospital · Oulu · NCT06282952

• Using fecal microbiota transplantation to reduce colorectal adenoma recurrence

  This study tests if a treatment using healthy gut bacteria can help prevent the return of colorectal adenomas in patients who have had them removed.

  Recruiting Phase 2 Shenzhen Hospital of Southern Medical University · Guangzhou, Guangdong and 4 other locations · NCT06205862

• Using fecal transplantation to eliminate drug-resistant bacteria

  This study is testing whether using fecal transplants can help adults get rid of harmful drug-resistant bacteria in their gut.

  Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Clichy and 10 other locations · NCT05035342

• Restoring gut bacteria in patients with Crohn's disease

  This study is testing whether a treatment using healthy gut bacteria can help people with active Crohn's disease feel better.

  Recruiting Phase 1/2 St Vincent's Hospital Melbourne · Melbourne, Victoria · NCT04970446

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.