Decompensated cirrhosis complicated by ascites is characterised by gut dysbiosis and bacterial translocation, processes that contribute to persistent systemic immune activation and increase risk of inflammatory complications such as acute-on-chronic liver failure (ACLF). At present, no licensed interventions specifically restore intestinal barrier function or reverse dysbiosis for this vulnerable group. Prior research has suggested potential benefits of faecal microbiota transfer (FMT) in related liver conditions, including hepatic encephalopathy and alcohol-associated hepatitis, but evidence on safety and immunomodulatory effects of FMT in patients with decompensated cirrhosis and ascites is limited.
The TransImmune trial is designed as a Phase IIa pilot to address these gaps by evaluating an encapsulated FMT product for safety, tolerability, feasibility, and signals of biological effect on intestinal and systemic inflammatory processes.
TransImmune is a prospective, single-centre, randomised, double-blind, placebo-controlled Phase IIa pilot study. The protocol enrols a total of 24 patients with decompensated cirrhosis and ascites, randomised in a 1:1 ratio to receive either encapsulated FMT or placebo. Participants will be followed across five study visits with monitoring extending to 90 days after the intervention.
The investigational product used in this study is INTESTIFIX 001, an encapsulated FMT preparation derived from healthy donors. The material is produced under Good Manufacturing Practice (GMP) conditions by the Cologne Microbiota Bank (CMB). Donors undergo rigorous screening and the product is released only when it meets predefined specifications, including quality-control criteria such as minimum alpha-diversity thresholds. The product is administered in encapsulated form over three consecutive days.
Eligible participants are adults with decompensated cirrhosis and ascites. The source document does not provide the full inclusion and exclusion criteria or baseline demographic targets; those details were not reported in the source summary.
Participants are randomised 1:1 to receive either the encapsulated FMT product or placebo. The intervention is given over three consecutive days. The study is double-blind to participants and investigators. Specific details on randomisation method, concealment, placebo composition, and procedures to maintain blinding were not reported in the source summary.
The co-primary objectives focus on safety and tolerability. Primary endpoints are:
Secondary endpoints are intended to detect signals of clinical efficacy and biological effect. These include assessments of:
The trial will also evaluate feasibility outcomes and microbial engraftment as part of exploratory analyses.
Participants will be monitored over five study visits spanning up to 90 days post-intervention. The primary safety assessments capture SAEs and TEAEs throughout this period. Further details on adverse event grading, stopping rules, or data safety monitoring committee structure were not specified in the summary.
Beyond clinical safety and standard laboratory markers, the protocol intends to assess microbial engraftment of the administered FMT and downstream effects on intestinal barrier integrity and both systemic and peritoneal inflammation. Specific assays, sampling schedules, or molecular methods for measuring engraftment and barrier integrity were not detailed in the source summary.
The study obtained approval from an ethics committee and from the German Federal Institute for Drugs and Medical Devices (BfArM). The trial is registered in the EU Clinical Trials Register with number 2023-507790-18-00 and was registered on 8 August 2024.
The investigators plan to disseminate study findings through peer-reviewed journal publications and presentations at international conferences. No further dissemination timelines or publication policies were provided in the source summary.