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NCT01696227 · ClinicalTrials.gov registry record

Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

A clinical trial, sponsored by Nationwide Children's Hospital.

Completed
Registry status
50
Enrollment target

NCT01696227: Completed study, sponsored by Nationwide Children's Hospital.

NCT01696227 is a clinical trial that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01696227 has completed, sponsored by Nationwide Children's Hospital.

COMPLETED
Registry status
50 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Nissle 1917

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2012-07
Est. Completion 2014-06
Nationwide Children's Hospital

188 total trials

What the finished NCT01696227 record still lists

NCT01696227 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Nissle 1917 is the first listed.

NCT01696227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01696227 about?

NCT01696227 is a clinical study titled "Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children". 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 show...

What is the current status of trial NCT01696227?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2012-07. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01696227?

The interventions under investigation include: Nissle 1917 (DRUG).

Who is sponsoring clinical trial NCT01696227?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01696227, the US trial registry maintained by the National Library of Medicine. NCT01696227 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.