Controlled Human Urine Transfusion for UTI
NCT03142295 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2017-06-26
Summary
The primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's.
Seconday and exploratory objectives are to evaluate the diversity of the urine microbiome after urine transfusion, to assess the longevity of changes in the urine microbiome in patients after urine transfusion over a period of 6 months and to assess the frequency of UTI's after the transfusion.
Conditions
- Recurrent Urinary Tract Infection
- Safety Issues
Interventions
- PROCEDURE
-
urine transfusion
Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days.
Sponsors & Collaborators
-
Leiden University Medical Center
lead OTHER
Principal Investigators
-
Imro Vlasveld, MD · LUMC
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-24
- Primary Completion
- 2018-01-01
- Completion
- 2018-02-01
Countries
- Netherlands
Study Locations
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