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Application of Clinical Metagenomics in the Diagnosis of Ascites

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04131751
Enrollment
50
Registered
2019-10-18
Start date
2019-10-01
Completion date
2021-10-01
Last updated
2021-11-01

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

Conditions

Ascites Infection

Keywords

Metagenomics

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.

Interventions

DIAGNOSTIC_TESTNext generation sequencing

we will investigate the sensitivity and specificity of next generation sequencing as a diagnostic tool in ascites infections.

Sponsors

University Hospital Freiburg
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The comparative assessment of about 50 patients12-18 Months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026