TY - JOUR
T1 - Cirrhosis and Faecal microbiota Transplantation (ChiFT) protocol
T2 - a Danish multicentre, randomised, placebo-controlled trial in patients with decompensated liver cirrhosis
AU - Støy, Sidsel
AU - Eriksen, Lotte Lindgreen
AU - Lauszus, Johanne Sloth
AU - Damsholt, Søren
AU - Baunwall, Simon Mark Dahl
AU - Erikstrup, Christian
AU - Vilstrup, Hendrik
AU - Jepsen, Peter
AU - Hvas, Christian
AU - Thomsen, Karen Louise
N1 - © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025/2/12
Y1 - 2025/2/12
N2 - Introduction Liver cirrhosis is a progressive disease with high mortality. Gut microbiota derangement, increased gut permeability, bacterial translocation and chronic inflammation all drive disease progression. This trial aims to investigate whether faecal microbiota transplantation (FMT) may improve the disease course in patients with acute decompensation of liver cirrhosis. Methods and analysis In this Danish, multicentre, randomised, double-blinded, placebo-controlled trial, 220 patients with acute decompensation of liver cirrhosis and a Child-Pugh score≤12 will be randomised (1:1) to oral, encapsulated FMT or placebo in addition to standard of care. Before the intervention, the patients will be examined and biological samples obtained, and this is repeated at 1 and 4 weeks and 3, 6 and 12 months after the intervention. The primary outcome is the time from randomisation to new decompensation or death. Secondary endpoints include mortality, number of decompensation events during follow-up and changes in disease severity and liver function. Ethics and dissemination The Central Denmark Region Research Ethics Committee approved the trial protocol (no. 1-10-72-302-20). The results will be published in an international peer-reviewed journal, and all patients will receive a summary of the results.
AB - Introduction Liver cirrhosis is a progressive disease with high mortality. Gut microbiota derangement, increased gut permeability, bacterial translocation and chronic inflammation all drive disease progression. This trial aims to investigate whether faecal microbiota transplantation (FMT) may improve the disease course in patients with acute decompensation of liver cirrhosis. Methods and analysis In this Danish, multicentre, randomised, double-blinded, placebo-controlled trial, 220 patients with acute decompensation of liver cirrhosis and a Child-Pugh score≤12 will be randomised (1:1) to oral, encapsulated FMT or placebo in addition to standard of care. Before the intervention, the patients will be examined and biological samples obtained, and this is repeated at 1 and 4 weeks and 3, 6 and 12 months after the intervention. The primary outcome is the time from randomisation to new decompensation or death. Secondary endpoints include mortality, number of decompensation events during follow-up and changes in disease severity and liver function. Ethics and dissemination The Central Denmark Region Research Ethics Committee approved the trial protocol (no. 1-10-72-302-20). The results will be published in an international peer-reviewed journal, and all patients will receive a summary of the results.
KW - Adult
KW - Denmark
KW - Disease Progression
KW - Double-Blind Method
KW - Fecal Microbiota Transplantation/methods
KW - Female
KW - Gastrointestinal Microbiome
KW - Humans
KW - Liver Cirrhosis/therapy
KW - Male
KW - Multicenter Studies as Topic
KW - Randomized Controlled Trials as Topic
KW - Treatment Outcome
KW - Randomised Controlled Trial
KW - Hepatobiliary disease
KW - Microbiota
KW - Hepatology
UR - http://www.scopus.com/inward/record.url?scp=85218088332&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2024-091078
DO - 10.1136/bmjopen-2024-091078
M3 - Journal article
C2 - 39938959
SN - 2044-6055
VL - 15
SP - e091078
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e091078
ER -