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

Suspended
Conditions
K65
K74.6
Peritonitis
Other and unspecified cirrhosis of liver
Registration Number
DRKS00026834
Lead Sponsor
Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar der TU München
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
All
Target Recruitment
120
Inclusion Criteria

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

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

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) Analysis of the gastrointestinal microbiome in patients with SBP: <br>• Description of the microbiome in those patients in specimen of the oral cavity, the duodenum, the ascites and the stool<br>• Comparison of the microbiome of patients with and without SBP
Secondary Outcome Measures
NameTimeMethod
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. <br>3) Changes in the microbiome as risk factor of SBP.<br>• Multivariate regression analysis of SBP risk factors<br>• Association of pathogens in ascites / ascitic microbiome with changes in the intestinal microbiome
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