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Multicompartmental analysis of the microbiome in the context of liver transplants

Multicompartmental analysis of the microbiome in the context of liver transplants - LTXMicrobiome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039499
Enrollment
15
Registered
2026-03-02
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation in end-stage liver disease (particularly metabolic/nutritional cirrhosis)

Interventions

Group 1: Participants undergo guideline-based liver transplantation without any study-related therapeutic intervention. Prospective sample collection only (blood, stool, bile and liver tissue) is perf

Sponsors

Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Listed for elective liver transplantation at the participating centre. • Clinically stable at the time of informed consent. • Willingness and ability to provide preoperative stool samples and attend the specified follow-up appointments (up to 12 months). • Familiarity with the study requirements or sufficient language skills to understand the consent form and instructions.

Exclusion criteria

Exclusion criteria: • High-urgency or emergency transplantation (not a planned elective procedure), as preoperative samples and standardised information cannot be guaranteed. • Inability to give informed consent (e.g. lack of cognitive ability, lack of language skills without an interpreter), or unwillingness to participate/follow up. • Transplantation in combination with other organs (e.g. liver-kidney) or planned simultaneous major procedures if this significantly alters post-operative care and sample collection.

Design outcomes

Primary

MeasureTime frame
Quantitative change in the concentration of Enterococcus faecalis in bile (log10 cells/ml) across predefined perioperative time points of liver transplantation (explant liver, implanted liver intraoperatively, postoperative day 1, 7 and 14).

Secondary

MeasureTime frame
• Change in concentrations of primary and secondary bile acids in bile (ng/ml) at predefined perioperative time points • Change in Torque Teno Virus load in blood (copies/ml) at predefined perioperative time points • Change in clinical liver function parameters (ALT, AST, bilirubin, albumin, INR) over time after transplantation

Countries

Germany

Contacts

Public ContactFabian Haak

Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie

fabian.haak@medizin.uni-leipzig.de+49 151 425 22 301

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026