Bartonella in Liver Transplant Patients

Cryptogenic Chronic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595710
• Other study ID #: 1312m46162
• Status: Completed
• Start date: December 2013
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryptogenic Chronic Hepatitis
• Cryptogenic Cirrhosis
• Hepatitis
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM)		90 weeks