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Clinical Trials in Denmark / NCT04932577
Recruiting Phase 2/3

Faecal Microbiota Transplantation for Liver Cirrhosis

NCT04932577 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Phase 2/3
Started
2021-07-01
Last updated
2025-01-24

Condition(s) studied

Liver Cirrhosis

Investigational drug(s) / intervention(s)

Faecal microbiota transplantation →Placebo

Faecal microbiota transplantation: All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.

Placebo: Placebo

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients. — 1 year
    Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the two groups, hazard ratios will be calculated.

Trial sites (1)

FacilityCityRegionStatus
Department of Hepatology and Gastroenterology, Aarhus University Hospital Aarhus Denmark Recruiting

More University of Aarhus trials in Denmark

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IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer Active, not recruiting
Danish Access to Support and Help (DASH): Increasing Access to an Evidence-based Intervention for Children With ADHD and Their Parents Enrolling by invitation

Other trials for the same condition

Palliative Care for Patients With Liver Cirrhosis Enrolling by invitation
Diagnosing Minimal Hepatic Encephalopathy Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04932577 on ClinicalTrials.gov ↗ ← All trials in Denmark