Application of Clinical Metagenomics in the Diagnosis of Ascites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-01

Brief Summary

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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

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Conditions

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Ascites Infection

Keywords

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Metagenomics

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Next generation sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Mohamed Tarek Badr

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Tarek Badr, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Microbiology and Hygiene, Hermann-Herder-Str. 11, 79104 Freiburg

Locations

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Institute for Microbiology and Hygiene

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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246/19

Identifier Type: -

Identifier Source: org_study_id