Safety Issues Clinical Trial
Official title:
Safety and Tolerability of Controlled Human Urine Transfusion for Urinary Tract Infection Prevention (SHUTUP): a Pilot Study
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.
Recurrent urinary tract infections (UTIs) are the most common bacterial infections in
nursing homes, in acute care and the general practice. Increasing antibiotic resistance of
enterobacteriaciae poses a challenge to the treatment of UTIs. Unlike previously thought,
the bladder is colonized with bacteria, which together form the urine microbiome. Recurrent
urinary tract infections are associated with a decreased urinary microbiota diversity,
potentially making recolonization by bacterial interference in the bladder an alternative
therapy for UTI. Pioneering studies showed that local bacterial interference in the bladder
can be performed safely and has potential as prophylactic intervention.
We now propose to expand this bacterial interference to a polymicrobial inoculum to increase
adherence of the donor microbiome and as such expand the prophylactic effect. This pilot
trial will investigate the safety and tolerability of urine transfusion from healthy donors
to the bladders of patients with recurrent UTIs.
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.
Secondary 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.
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