Application of Clinical Metagenomics in the Diagnosis of Ascites

Completed

• Conditions: Ascites Infection

• Registration Number: NCT04131751
• Lead Sponsor: University Hospital Freiburg

Brief Summary

Infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. This fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. Many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. Culture-independent approaches such as NGS (Next generation Sequencing) have in principle made it possible to study or prove complex microbial colonization. Because NGS is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. For microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. Afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. In this study the investigators plan to use these samples to analyze and compare the presence of bacteria by NGS in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-18
• Primary Completion: 2021-06-01
• Status Verified: 2021-10
• Study Completion: 2021-10-01
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male and female patients ≥ 18 years of age
• Samples from patients who have ascites puncture to exclude infection
• Written consent of the patient after clarification

Exclusion Criteria

• Minor patients
• Non-consenting patients
• Samples without sufficient residual material after standard diagnostics
• Samples from patients who have not consented to the examination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparative assessment of about 50 patients	12-18 Months

Trial Locations

Locations (1)

Institute for Microbiology and Hygiene; 🇩🇪 Freiburg, Baden Württemberg, Germany