Bartonella in Liver Transplant Patients

March 1, 2022 updated by: University of Minnesota

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

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..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM)
Time Frame: 90 weeks
90 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Marna E Ericson, phd, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1312m46162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share individual patient data (IPD) with other researchers upon requet.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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