To investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI*s.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Frequency and magnitude of adverse events within 6 months of controlled human
urine transfusion, including the occurrence of UTI*s that are possibly,
probably or definitely related to the transfusion procedure.
So concrete: total amount of adverse events, serious adverse events and
suspected unexpected serieous adverse reactions.
Secondary outcome
- Urine microbiome composition and diversity by total amount of genus,
percentage of genus and the Shannon diversity index before and after urine
transfusion.
- Time to change (in days) of urine microbiome composition and diversity
- Frequency of UTI*s (in exact amounts) after urine transfusion.
Background summary
Almost half of all women will experience one UTI during their lifetime. Urinary
tract infections (UTIs) are the most common bacterial infections at the general
practice, in acute care and in nursing homes. The increasing incidence of
resistant enterobacteriaciae poses a threat to the antibiotic treatment of UTI.
Following the discovery of the bladder microbiome, it was found that urinary
tract infections are associated with a decreased urinary microbiome diversity,
opening up avenues for bacterial interference as alternative strategies to
antibiotic treatment.
We hypothesize that instillation of the bladder with a polymicrobial inoculum
will increase the bladder microbiota diversity in patients with recurrent UTI*s
and as such may increase the beneficial effects of bacterial interference. In
addition, we believe that urine from healthy donors potentially may be the most
suitable inoculum for long lasting colonization of the bladder epithelium.
Study objective
To investigate the safety and tolerability of controlled human urine
transfusion in female patients with recurrent UTI*s.
Study design
This will be a prospective, open label pilot clinical trial.
Intervention
Two transfusions of 100 ml of urine within 5 days by transurethral
catheterization after an antibiotic free interval of 3 days.
Study burden and risks
Patients with recurrent UTI*s will be recruited from the general practice and
from the infectious diseases outpatient department and offered transfusion
after an antibiotic free interval of 3 days. Blood, urine and faeces samples
will be taken at the screening visits. The urine transfusion procedure will be
performed twice within 5 days through transurethral catheterization. Recipients
will visit the trial centre at day 3 after the last transfusion, weekly for 4
weeks and after 3 and 6 months. Urine sampling by voided urine will take place
at every visit. Urine collected by transurethral catheterization will take
place on both transfusion days and 1 week and 1 month after the urine
transfusion. Urethral swaps will be done twice for patients. Two other patient
faeces samples will be collected 1 week and 1 month after transfusion.
Patients may experience adverse events following TUC, such as
catheter-associated UTI. However, the chance on developing an
catheter-associated UTI after single catheterization is small and estimated
around 1-5%. A cystitis after catheterization is mostly a harmless condition
with a conservative approach. In case of an UTI during the follow-up patients
will be treated with antibiotics according to standard of care.
Trauma related to the transurethral catheterisation, such as urethra, bladder
or rectum injury are very rare if performed by a skilled nurse or physician.
Potential adverse events during the urine transfusions can be: bladder spasms,
(lower) abdominal pain, and transfusion of resistant micro-organisms. For the
latter, donors got screened for potential carriage of resistant
micro-organisms. .
There is no benefit of participation in this pilot trial for the donors.
Potentially, patients may benefit from participation if the urine transfusion
prevents subsequent UTIs.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60330.058.16 |
| Other | volgt |