Bartonella in Liver Transplant Patients

Study Overview
=================
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.

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

Conditions
-----------------
Cryptogenic Cirrhosis, Cryptogenic Chronic Hepatitis

Intervention / Treatment
-----------------
* Other: skin punch biopsy collection
* Other: Blood collection
* Other: Urine sample collection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biospecimen retention<br>Blood Collection Skin Punch Biopsy Collection Urine Sample Collection | Other: skin punch biopsy collection<br>* 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.<br>Other: Blood collection<br>* 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.<br>Other: Urine sample collection<br>* Urine samples will be collected and analyzed for Bartonella spp specific microRNAs.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryptogenic Chronic Hepatitis, Bartonellosis