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Ascitic Fluid Microbiome in Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813590
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
CBmed - Center for biomarker research in medicine
Information provided by (Responsible Party):
Medical University of Graz

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.


Condition or disease Intervention/treatment
Ascitic Fluid, Microbiota Microbiota Sequence Analysis Polymerase Chain Reaction Other: Ascitic fluid puncture Other: Skin swaps from puncture side Other: Stool samples

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Next generation sequencing results from ascitic fluid samples [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with underlying liver cirrhosis and ascitic fluid that is routinley punctured.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813590


Locations
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Austria
Medical University of Graz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
CBmed - Center for biomarker research in medicine
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02813590    
Other Study ID Numbers: 25-326 ex 12/13
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018