Bartonella in Liver Transplant Patients

NCT02595710 | Completed

• 1 other identifier: 1312m46162
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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..

Conditions

Cryptogenic Cirrhosis; Cryptogenic Chronic Hepatitis

Keywords

Cryptogenic Chronic Hepatitis; Bartonellosis

Outcome Measures

Primary Outcomes (1)

• Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM)

  90 weeks

Study Arms (1)

Biospecimen retention

Blood Collection Skin Punch Biopsy Collection Urine Sample Collection

Other: skin punch biopsy collection; Other: Blood collection; Other: Urine sample collection

Interventions

skin punch biopsy collection 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.

Biospecimen retention

Blood collection 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.

Biospecimen retention

Urine sample collection OTHER

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

Biospecimen retention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• o Male and female subjects, ages 18 years and older
• Liver transplant recipient
• Diagnosis of cryptogenic cirrhosis
• Signed consent form

You may not qualify if:

• none

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Alpha Proteobacterium Growth Medium (BAPGM) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques. Four-mm 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. Urine samples will be collected and analyzed for microRNAs. Blood smears will be analyzed for intra-erythrocytic Bartonella spp.

MeSH Terms

Conditions

Cirrhosis, Cryptogenic; Hepatitis, Chronic; Bartonella Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bartonellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marna E Ericson, phd

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: November 3, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)