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Trial record 51 of 340 for:    liver transplant | Recruiting, Not yet recruiting, Available Studies

Bartonella in Liver Transplant Patients

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ClinicalTrials.gov Identifier: NCT02595710
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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..

Condition or disease Intervention/treatment
Cryptogenic Cirrhosis Cryptogenic Chronic Hepatitis Other: skin punch biopsy collection Other: Blood collection Other: Urine sample collection

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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Undetected Bartonella Spp. Infection Puts Liver Transplant Patients at Great Risk
Study Start Date : December 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Group/Cohort Intervention/treatment
Biospecimen retention
Blood Collection Skin Punch Biopsy Collection Urine Sample Collection
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.

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.

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




Primary Outcome Measures :
  1. Liver transplant subject that show evidence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM) [ Time Frame: 90 weeks ]

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595710


Contacts
Contact: Marna E Ericson, phd 6126242995 erics004@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Marna E Ericson, phd    612-624-2995    erics004@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Marna E Ericson, phd University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02595710     History of Changes
Other Study ID Numbers: 1312m46162
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share individual patient data (IPD) with other researchers upon requet.

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cryptogenic Chronic Hepatitis
Bartonellosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases