Faecal Microbiota Transplantation for Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Faecal microbiota transplantation, Placebo.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
Overview
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.
Interventions
- Biological Faecal microbiota transplantation
All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year. - Biological Placebo
Placebo
Primary outcome measures
- Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients. [Time frame: 1 year]
Secondary outcome measures (12)
- Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients at 3 months and 6 months of follow-up. [Time frame: 3 months, 6 months]
- Number of new decompensations and deaths during follow-up in the FMT versus the placebo-treated patients. [Time frame: 1 year]
- Time to death in FMT versus placebo-treated patients. -treated patients at 3 months and 6 months of follow-up. [Time frame: 1 year, 6 months, 3 months]
- Change in gut microbiota beta-diversity (Bray-Curtis index) during one year in FMT versus placebo-treated patients by shotgun metagenomic sequencing. [Time frame: 1 year, 6 months, 3 months]
- Change in plasma concentration of gut translocation markers; lipopolysaccharide binding protein, soluble CD14, fatty acid binding protein 1 during one year in FMT versus placebo-treated patients by ELISA. [Time frame: 1 year, 6 months, 3 months]
- Change in plasma and stool concentration of pro- and antiinflammatory cytokines; IL-6, IL-1beta, TNF-alpha, IL-8, IL-10 in response to the intervention by luminex. [Time frame: 1 year, 6 months, 3 months]
- Change in disease severity in FMT- versus placebo-treated patients. [Time frame: 3 months, 6 months, 1 year.]
- Change in disease severity in FMT- versus placebo-treated patients. [Time frame: 3 months, 6 months, 1 year.]
- Change in disease severity in FMT- versus placebo-treated patients. [Time frame: 3 months, 6 months, 1 year.]
- Change in metabolic liver function in FMT- versus placebo-treated patients. [Time frame: 3 months, 6 months, 1 year.]
- Change in liver stiffness in FMT- versus placebo-treated patients. [Time frame: 3 months, 6 months, 1 year.]
- Change in the Liver Frailty Index in FMT- versus placebo-treated patients. [Time frame: 3 months, 6 months, 1 year.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Hepatology and Gastroenterology, Aarhus University Hospital — Aarhus
Publications
- Stoy S, Eriksen LL, Lauszus JS, Damsholt S, Baunwall SMD, Erikstrup C, Vilstrup H, Jepsen P, Hvas C, Thomsen KL. Cirrhosis and Faecal microbiota Transplantation (ChiFT) protocol: a Danish multicentre, randomised, placebo-controlled trial in patients with decompensated liver cirrhosis. BMJ Open. 2025 Feb 12;15(2):e091078. doi: 10.1136/bmjopen-2024-091078. PMID 39938959
Identifiers
NCT: NCT04932577 · 1-10-72-302-20