Safety and tolerability of controlled Human Urine Transfusion for Urinary tract infection Prevention (SHUTUP): a pilot study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1. Subject is premenopausal, aged * 18 and *45 years
2. Subject had recurrent UTI*s (*3 documented UTI*s in the last year with
documented symptom-free interval of at least 2 weeks) following the definition
of a urinary tract infection: the presence of significance bacteruria (103
CFU/ml or more), pyuria and fever plus one or more of the following signs and
symptoms: suprapubic or flank discomfort, dysuria, bladder spasms or pollakiuria
3. Subject has a documented urinary tract infection (see definition), for which
oral antibiotic therapy has been initiated.
4. Subject has adequate understanding of the procedures of the study and agrees
to abide strictly thereby.
5. Subject is able to communicate well with the investigators and is available
to attend all study visits.
6. Subject has signed informed consent.
7. Subject will remain available during the first 3 weeks of the study period

Exclusion Criteria

1. Any history or evidence at screening of clinically significant symptoms,
physical signs or abnormal laboratory values suggestive of systemic conditions.
2. 2. Documented vesico-urethral reflux
3. Documented urinary retention > 100 milliliters post-void residual urine
4. Anatomic urogenital abnormalities
5. Urolithiasis
6. Nephrostomy catheters
7. Extraurogenital infections that require prolonged antibiotic therapy
8. Pregnancy
9. Use of probiotics and or cranberry juice
10. Allergy or intolerance for multiple common prescribed antibiotics
11. Carriage of multi drug resistant organisms in faeces and/or urine without
regular antibiotic treatment options

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Frequency and magnitude of adverse events within 6 months of controlled human<br /><br>urine transfusion, including the occurrence of UTI*s that are possibly,<br /><br>probably or definitely related to the transfusion procedure.<br /><br><br /><br>So concrete: total amount of adverse events, serious adverse events and<br /><br>suspected unexpected serieous adverse reactions. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Urine microbiome composition and diversity by total amount of genus,<br /><br>percentage of genus and the Shannon diversity index before and after urine<br /><br>transfusion.<br /><br>- Time to change (in days) of urine microbiome composition and diversity<br /><br>- Frequency of UTI*s (in exact amounts) after urine transfusion.</p><br>