Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 to 75

Using fecal microbiota transplantation to treat liver cirrhosis

Official title: Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis

Run by University of Aarhus · NCT04932577 · Data updated 2026-11-12

This study is testing if a treatment called fecal microbiota transplantation can help people with liver cirrhosis feel better and reduce complications.

More Liver Cirrhosis trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment220 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations1 site (Aarhus)
StatusRecruiting
StartedJuly 1, 2021
Main results expectedMay 31, 2026
Study endsMay 31, 2027
Registry record updatedJanuary 24, 2025
Trial IDNCT04932577 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-75 with liver cirrhosis and acute decompensation requiring intervention.

Probably not a fit

Patients with multiple organ failures, untreated malignancies, or certain infections and diseases may not benefit from this study.

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 effects of fecal microbiota transplantation (FMT) on patients with liver cirrhosis, particularly focusing on complications, disease progression, and mortality. The study will randomly assign 220 patients experiencing acute decompensation of liver cirrhosis into two groups: one receiving FMT and the other receiving a placebo. Researchers will monitor the patients for one year to assess changes in gut microbiota, gut barrier function, systemic inflammation, and immune response, aiming to understand the mechanistic effects of FMT on liver disease.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the prognosis and quality of life for patients with liver cirrhosis.

How similar studies have gone: Previous studies have shown promising results with fecal microbiota transplantation in various conditions, suggesting potential success in this novel application for liver cirrhosis.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

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

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.