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Influence of the intestinal microbiome on the risk of spontaneous bacterial peritonitis in patients with decompensated liver cirrhosis

Influence of the intestinal microbiome on the risk of spontaneous bacterial peritonitis in patients with decompensated liver cirrhosis - IMPAC trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00026834
Enrollment
120
Registered
2021-12-03
Start date
2021-12-05
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K65 K74.6

Interventions

Group 1: patients, who develop a nosocomial SBP: patients are recruited and samples collected after exclusion of SBP at initial paracentesis. In case of SBP in a later paracentesis samples are collec

Sponsors

Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar der TU München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients with liver cirrhosis (confirmed by ultrasound, CT or histology) and ascites - indication for paracentesis

Exclusion criteria

Exclusion criteria: - age <18 years - unable to give informed consent - pregnancy - SBP at admission - antibiosis within 14 days prior to recruitment - status post liver transplantation - pharmacological or acquired (e.g. HIV) immune deficiency - surgery within 6 months prior to recruitment - status post colectomy - active neoplastic disease - secondary peritonitis - patients on ICU - cirrhose cardiac - cleansing for colonoscopy

Design outcomes

Primary

MeasureTime frame
1) Analysis of the gastrointestinal microbiome in patients with SBP: • Description of the microbiome in those patients in specimen of the oral cavity, the duodenum, the ascites and the stool • Comparison of the microbiome of patients with and without SBP

Secondary

MeasureTime frame
2) Analysis of oral overgrowth of the microbiome in the small intestine by typical oral bacteria by comparison of duodenal and faecal with oral (saliva) samples. 3) Changes in the microbiome as risk factor of SBP. • Multivariate regression analysis of SBP risk factors • Association of pathogens in ascites / ascitic microbiome with changes in the intestinal microbiome

Countries

Germany

Contacts

Public ContactSebastian Rasch

Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar der TU München

sebastian.rasch@mri.tum.de00498941400

Outcome results

None listed

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