Ascitic Fluid Microbiome in Liver Cirrhosis | NCT02813590

Studies
Ascitic Fluid Microbiome in Liver Cirrhosis

NCT02813590

Sponsor

Medical University of Graz

Status

Withdrawn

Last Update Posted

Mar 15, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Ascitic Fluid, Microbiota
Microbiota
Sequence Analysis
Polymerase Chain Reaction

Interventions

Ascitic fluid puncture
Skin swaps from puncture side
Stool samples

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Jun 16, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 15, 2024Actual

Name	Class
CBmed - Center for biomarker research in medicine	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with liver cirrhosis and with SBP			Other: Ascitic fluid puncture Other: Skin swaps from puncture side Other: Stool samples
Patients with liver cirrhosis and without SBP			Other: Ascitic fluid puncture Other: Skin swaps from puncture side Other: Stool samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ascitic fluid puncture	Other		Patients with liver cirrhosis and with SBP Patients with liver cirrhosis and without SBP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Next generation sequencing results from ascitic fluid samples		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Underlying decompensated liver cirrhosis
routinely performed ascitic fluid puncture
informed consent

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz	Styria	8036	Austria