Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date June 16, 2016
First Posted Date June 27, 2016
Last Update Posted Date March 22, 2018
Actual Study Start Date June 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2016)
Next generation sequencing results from ascitic fluid samples [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ascitic Fluid Microbiome in Liver Cirrhosis
Official Title Not Provided
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with underlying liver cirrhosis and ascitic fluid that is routinley punctured.
Condition
  • Ascitic Fluid, Microbiota
  • Microbiota
  • Sequence Analysis
  • Polymerase Chain Reaction
Intervention
  • Other: Ascitic fluid puncture
  • Other: Skin swaps from puncture side
  • Other: Stool samples
Study Groups/Cohorts
  • Patients with liver cirrhosis and with SBP
    Interventions:
    • Other: Ascitic fluid puncture
    • Other: Skin swaps from puncture side
    • Other: Stool samples
  • Patients with liver cirrhosis and without SBP
    Interventions:
    • Other: Ascitic fluid puncture
    • Other: Skin swaps from puncture side
    • Other: Stool samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 21, 2018)
12
Original Estimated Enrollment
 (submitted: June 22, 2016)
30
Actual Study Completion Date September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT02813590
Other Study ID Numbers 25-326 ex 12/13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical University of Graz
Study Sponsor Medical University of Graz
Collaborators CBmed - Center for biomarker research in medicine
Investigators Not Provided
PRS Account Medical University of Graz
Verification Date March 2018