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Clinical Trials/NCT01696227
NCT01696227
Completed
Not Applicable

Targeted Pathogen Replacement With Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

Nationwide Children's Hospital1 site in 1 country50 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Nissle 1917
Conditions
Recurrent UTIs
Sponsor
Nationwide Children's Hospital
Enrollment
50
Locations
1
Primary Endpoint
Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Background:

Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children. Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure, pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has not shown improvement of the risk of these diseases, and contributes to the growing public health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria living in our bowels for a more harmless variety.

Hypothesis and specific aims:

Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract problems that require use of catheters to empty their bladders.

Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species, Enterococcus species, and Klebsiella species to live in the same environment with the probiotic bacteria to see how the numbers of each bacteria change.

Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge them to live in the same environment as the probiotic bacteria.

Potential Impact:

This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless bacteria and reduces the use of antibiotics overall in the community.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Lucas

Fellow MD

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with urinary catheters placed that will be getting them removed

Exclusion Criteria

  • Patient's currently getting treated for UTI

Arms & Interventions

Nissle 1917

In vitro, Nissle 1917's ability to adversely affect the growth of uropathogens associated with urinary catheters and those with a known GI resevoir will be measured.

Intervention: Nissle 1917

Outcomes

Primary Outcomes

Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens

Time Frame: 2 years

Uropathogens obtained from discarded clinical samples will be challenged to live in the same environment as the probiotic, Nissle 1917. Colonies of uropathogens and Nissle 1917 will be counted as a measure of the more successful organism as well as, zone of inhibition will be measured in co-cultures.

Study Sites (1)

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