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Clinical Trial Summary

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


Clinical Trial 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 study we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as a faecal microbiota transplantation (FMT). In this this study 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 in these patients. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04932577
Study type Interventional
Source University of Aarhus
Contact Karen Louise Thomsen, PhD
Phone +4526949260
Email karethom@rm.dk
Status Recruiting
Phase Phase 2/Phase 3
Start date July 1, 2021
Completion date May 31, 2027

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