NCT04932577

Faecal Microbiota Transplantation for Liver Cirrhosis

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with liver disease have a disturbed gut microbiota. This is often associated with disease progression and development of complications, so-called episodes of decompensation. In this trial, we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as faecal microbiota transplantation (FMT). We will examine the effect of FMT on the prognosis and disease progression of the patients. Further, we will examine the mechanistic effects of FMT. We will at random divide 220 patients admitted with decompensation of liver cirrhosis evenly into two groups. One group will receive FMT and the other group will receive placebo. After the treatment, we will follow the patients for one year and examine disease progression as well as changes in their gut microbiota, gut barrier, and immune function.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	Faecal microbiota transplantation	All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-07-01
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2021-06-21
• Last updated: 2025-01-24

Locations

1 site across 1 country: Denmark