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NCT02813590 Clinical Trial

Ascitic Fluid Microbiome in Liver Cirrhosis

Microbiota Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02813590
Other study ID # 25-326 ex 12/13
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2016
Est. completion date September 2017

Study information
Verified date March 2024
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP). All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Underlying decompensated liver cirrhosis - routinely performed ascitic fluid puncture - informed consent Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ascitic fluid puncture

• Skin swaps from puncture side

• Stool samples

Locations
Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Graz CBmed - Center for biomarker research in medicine

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Next generation sequencing results from ascitic fluid samples 1 year
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