Bartonella in Liver Transplant Patients

NCT ID: NCT02595710

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2021-12-01

Brief Summary

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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..

Detailed Description

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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.

Conditions

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Cryptogenic Cirrhosis Cryptogenic Chronic Hepatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Biospecimen retention

Blood Collection Skin Punch Biopsy Collection Urine Sample Collection

skin punch biopsy collection

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Urine sample collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marna E Ericson, phd

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1312m46162

Identifier Type: -

Identifier Source: org_study_id

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