NCT02813590

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

June 16, 2016

Last Update Submit

March 12, 2024

Conditions

Ascitic Fluid, MicrobiotaMicrobiotaSequence AnalysisPolymerase Chain Reaction

Outcome Measures

Primary Outcomes (1)

  • Next generation sequencing results from ascitic fluid samples

    1 year

Study Arms (2)

Patients with liver cirrhosis and with SBP

Other: Ascitic fluid punctureOther: Skin swaps from puncture sideOther: Stool samples

Patients with liver cirrhosis and without SBP

Other: Ascitic fluid punctureOther: Skin swaps from puncture sideOther: Stool samples

Interventions

Ascitic fluid punctureOTHER
Patients with liver cirrhosis and with SBPPatients with liver cirrhosis and without SBP
Skin swaps from puncture sideOTHER
Patients with liver cirrhosis and with SBPPatients with liver cirrhosis and without SBP
Stool samplesOTHER
Patients with liver cirrhosis and with SBPPatients with liver cirrhosis and without SBP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with underlying liver cirrhosis and ascitic fluid that is routinley punctured.

You may qualify if:

  • Underlying decompensated liver cirrhosis
  • routinely performed ascitic fluid puncture
  • informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 27, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

AU(1)