Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03142295
Status:
UNKNOWN
Last Update Posted:
2017-06-26
First Post:
2017-05-03
Brief Title:
Controlled Human Urine Transfusion for UTI
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Safety and Tolerability of Controlled Human Urine Transfusion for Urinary Tract Infection Prevention SHUTUP a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHUTUP
Brief 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 UTIs
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 UTIs after the transfusion
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 UTIs after the transfusion
Detailed Description:
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 UTIs
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 UTIs after the transfusion
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 UTIs
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 UTIs after the transfusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None