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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 is a clinical trial that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 50 participants.
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.
Interventions
- DRUG Nissle 1917
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01696227
The ClinicalTrials.gov registry entry for NCT01696227 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nissle 1917 is the first listed.
NCT01696227 reports 0 study locations.
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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