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Recruiting Phase 2, Phase 3 NCT04932577

Faecal Microbiota Transplantation for Liver Cirrhosis

Trial Parameters

Condition Liver Cirrhosis
Sponsor University of Aarhus
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 220
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-07-01
Completion 2026-05-31
Interventions
Faecal microbiota transplantationPlacebo

Brief Summary

The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function.

Eligibility Criteria

Inclusion Criteria: * Age 18-75 years * Liver cirrhosis with Child-Pugh ≤ 12 * Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis) Exclusion Criteria: * More than one organ failure defined by CLIF-SOFA score * Untreated malignancy apart from non-melanoma skin cancer * Untreated viral hepatitis * HIV * Inflammatory bowel disease * Celiac disease * Clostridioides Difficile infection * Pregnancy * Unable to participate based on medical judgement

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