NCT04131751

Application of Clinical Metagenomics in the Diagnosis of Ascites

Establishing of Next Genaration Sequencing Methods for Microbiological Diagnostic of Ascitic Fluid Infections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ascites Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Next generation sequencing	we will investigate the sensitivity and specificity of next generation sequencing as a diagnostic tool in ascites infections.

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-06-01
• Completion: 2021-10-01
• First posted: 2019-10-18
• Last updated: 2021-11-01

Locations

1 site across 1 country: Germany