Faecal Microbiota Transplantation for Liver Cirrhosis
Key facts
- Who runs it
- University of Aarhus
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 220 people, planned
- Started
- 1 Jul 2021
- Expected to end
- 31 May 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Faecal microbiota transplantation
- Placebo
- Record updated
- 24 January 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Faecal microbiota transplantationTreatment being tested
The patients will receive three applications of FMT consisting of 50 g cryopreserved, homogenized faeces from healthy donors. The faecal material will be dispensed into double-coated, acid-resistant enterocapsules or cryobags. Faeces will be screened according to international guidelines.
- PlaceboPlacebo, for comparison
The placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
- Fit questions
- Built from NCT04932577, who can take part
- Record updated
- 24 January 2025