Faecal Microbiota Transplantation for Liver Cirrhosis
CHiFT
1 other identifier
interventional
220
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
January 24, 2025
December 1, 2024
4.9 years
May 26, 2021
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to death or new episode of acute decompensation requiring intervention in FMT 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 two groups, hazard ratios will be calculated.
1 year
Secondary Outcomes (16)
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.
3 months, 6 months
Number of new decompensations and deaths during follow-up in the FMT versus the placebo-treated patients.
1 year
Time to death in FMT versus placebo-treated patients. -treated patients at 3 months and 6 months of follow-up.
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.
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.
1 year, 6 months, 3 months
- +11 more secondary outcomes
Study Arms (2)
Faecal microbiota transplantation
EXPERIMENTALThe 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.
Placebo
PLACEBO COMPARATORThe placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products.
Interventions
All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Hvidovre University Hospitalcollaborator
- Aalborg Universitycollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
- Sjælland University Hospitalcollaborator
Study Sites (1)
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, 8200, Denmark
Related Publications (1)
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: 39938959DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 21, 2021
Study Start
July 1, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
January 24, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share