Faecal Microbiota Transplantation for Liver Cirrhosis (CHiFT)

University of Aarhus

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Liver Cirrhosis

Treatments: Biological: Placebo; Biological: Faecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04932577

1-10-72-302-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Faecal microbiota transplantation

Experimental group

Description:

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.

Treatment:

Biological: Faecal microbiota transplantation

Placebo

Placebo Comparator group

Description:

The placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products.

Treatment:

Biological: Placebo