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Bartonella in Liver Transplant Patients

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ClinicalTrials.gov Identifier: NCT02595710
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
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..

Condition or disease Intervention/treatment
Cryptogenic Cirrhosis Cryptogenic Chronic Hepatitis Other: skin punch biopsy collection Other: Blood collection Other: Urine sample collection

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Undetected Bartonella Spp. Infection Puts Liver Transplant Patients at Great Risk
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Biospecimen retention
Blood Collection Skin Punch Biopsy Collection Urine Sample Collection
 Other: skin punch biopsy collection
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.

Other: Blood collection
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.

Other: Urine sample collection
Urine samples will be collected and analyzed for Bartonella spp specific microRNAs.


Outcome Measures
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Primary Outcome Measures :
  1. Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM) [ Time Frame: 90 weeks ]

Biospecimen Retention:   Samples With DNA
Alpha Proteobacterium Growth Medium (BAPGM) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques. Four-mm 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. Urine samples will be collected and analyzed for microRNAs. Blood smears will be analyzed for intra-erythrocytic Bartonella spp.

Eligibility Criteria
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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:   Non-Probability Sample
Study Population
This study includes subjects ages 18 and above. Patients of the University of Minnesota Transplant Center who meet the inclusion/exclusion criteria will be given the opportunity to participate in this study. Dr. Lake has several liver transplant clinics and appropriate patients will be offered the opportunity to participate in this study.
Criteria

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
Contacts and Locations
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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): NCT02595710


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Marna E Ericson, phd University of Minnesota
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02595710    
Other Study ID Numbers: 1312m46162
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share individual patient data (IPD) with other researchers upon requet.
Keywords provided by University of Minnesota:
Cryptogenic Chronic Hepatitis
Bartonellosis
Additional relevant MeSH terms:
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Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases