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OpenTrials
Completed

NCT Number: NCT02595710

Bartonella in Liver Transplant Patients

Approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. Blood, skin and urine samples will be analyzed for Bartonella spp..

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Key information

About this study

Approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. Blood samples will be analyzed for Bartonella using the state-of-the art Bartonella Alpha Proteobacterium Growth Medium (BAPGM) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques. Blood smears will be analyzed for intra-erythrocytic Bartonella spp. Four-millimeter skin biopsies from non-lesional skin will be acquired from the same patients, processed using our published techniques, and imaged using confocal microscopy and compared to BAPGM test results. additionally, urine samples will be collected and analyzed for microRNAs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • o Male and female subjects, ages 18 years and older
  • Liver transplant recipient
  • Diagnosis of cryptogenic cirrhosis
  • Signed consent form

Exclusion criteria

  • none

Treatment and study plan

skin punch biopsy collection

Other

Four-mm skin biopsies from non-lesional skin will be acquired from the patients, processed using our published techniques with Bartonella biomarkers, and imaged using confocal microscopy.

Blood collection

Other

Blood will be tested for presence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques.Blood smears will be analyzed for presence of intra-erythrocytic Bartonella spp. by immunostaining.

Urine sample collection

Other

Urine samples will be collected and analyzed for Bartonella spp specific microRNAs.

Primary outcomes

  1. Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM)

    Time frame: 90 weeks

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Undetected Bartonella Spp. Infection Puts Liver Transplant Patients at Great Risk

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Nov 3, 2015
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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