Bartonella in Liver Transplant Patients

Completed

• Conditions: Cryptogenic Cirrhosis; Cryptogenic Chronic Hepatitis
• Interventions: Other: skin punch biopsy collection; Other: Blood collection; Other: Urine sample collection

• Registration Number: NCT02595710
• Lead Sponsor: University of Minnesota

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..

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• o Male and female subjects, ages 18 years and older

  • Liver transplant recipient
  • Diagnosis of cryptogenic cirrhosis
  • Signed consent form

Read More

Exclusion Criteria

• none

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biospecimen retention	skin punch biopsy collection	Blood Collection Skin Punch Biopsy Collection Urine Sample Collection
Biospecimen retention	Blood collection	Blood Collection Skin Punch Biopsy Collection Urine Sample Collection
Biospecimen retention	Urine sample collection	Blood Collection Skin Punch Biopsy Collection Urine Sample Collection

Primary Outcome Measures

Name	Time	Method
Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM)	90 weeks

Trial Locations

Locations (1)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States