RecruitingNot ApplicableNCT06782880

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

144 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fecal microbiota transplantation (FMT) — transferring beneficial gut bacteria from a healthy donor — can prevent serious infections in patients who are awaiting or have received a liver transplant. Liver transplant patients are highly vulnerable to dangerous bacterial infections. **You may be eligible if...** - You are 18 or older - You are on the waiting list for a liver transplant (for any reason) - You are willing to participate and provide consent **You may NOT be eligible if...** - You have had your entire colon removed - You are pregnant or breastfeeding - You are currently on oral or intravenous antibiotics - You have poorly controlled HIV or a very low immune cell count (CD4 < 200) - You have an active COVID-19 infection, severe low white blood cell count, toxic megacolon, or contraindications to colonoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFecal 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.


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT06782880


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