Faecal Microbiota Transplantation for Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— CHiFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932577
• Other study ID #: 1-10-72-302-20
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2021
• Est. completion date: May 31, 2027

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: Karen Louise Thomsen, PhD
• Phone: +4526949260
• Email: karethom[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

• Liver cirrhosis with Child-Pugh score 7-12

• Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, bacterial infections, hepatic encephalopathy, alcoholic hepatitis)

• Maximum of 1 organ failure defined by CLIF-SOFA score

Exclusion Criteria:

• Untreated malignancy apart from hepatocellular carcinoma within the Milan criteria or non-melanoma skin cancer

• Untreated viral hepatitis

• HIV

• Inflammatory bowel disease

• Celiac disease

• Pregnancy

• Unable to participate based on medical judgement

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Biological:
• Faecal microbiota transplantation
All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Department of Hepatology and Gastroenterology, Aarhus University Hospital	Aarhus

Sponsors (6)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University, Aalborg University Hospital, Aarhus University Hospital, Hvidovre University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death or re-admission due to episode of acute decompensation in FMT treated versus placebo treated patients.	Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the to groups, hazard ratios will be calculated.	1 year
Primary	Frequency of patients who have died or experienced a new episode of decompensation at 3 months of follow-up in FMT treated versus placebo treated patients.	At three months follow-up of the first 40 patients, we will conduct an interim analyses. The primary outcome measure is frequency of patients, who have died or developed a new episode of decompensation. We will draw the data from electronic patient charts and from follow-up visits. The frequency will be compared using Chi2 test.	3 months
Secondary	Change in gut microbiota beta-diversity (Bray-Curtis index, taxonomic abundance) during one year in FMT treated versus placebo treated patients by 16S sequencing.	In stool and saliva samples collected before and at 5 time points following the intervention, we will measure the gut microbiota composition.	1 year
Secondary	Change in plasma concentration of gut translocation markers; lipopolysaccharide binding protein, soluble CD14, fatty acid binding protein 1 during one year in FMT treated versus placebo treated patients by ELISA.	In blood samples collected at baseline and at follow-up visits, we will measure these plasma proteins by ELISA.	1 year
Secondary	Change in plasma concentration of pro- and antiinflammatory cytokines; IL-6, IL-1beta, TNF-alpha, IL-8, IL-10 in response to the intervention by luminex.	In blood samples collected at baseline and at follow-up visits, we will measure these plasma proteins by luminex.	1 year