An observational study in Recurrent UTIs and Catheter-Related Infections, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-10-15.
Sponsored by Nationwide Children's Hospital · Observational
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.
107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 25 observational studies indexed under Catheter-Related Infections.
Browse Catheter-Related Infections studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with urinary catheters that will be getting them removed
Exclusion Criteria:
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.
Drug: Nissle 1917
Uropathogens will be challenged to share the same in vitro environment with Nissle 1917.
Also known as: Probiotic, Mutaflor
Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens
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.
Time frame: 2 years
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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