Completed

Nissle 1917Targeted Pathogen Replacement With Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

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What is being collected

Drug Data

Collected from today forward - Prospective
DrugNo DNA Sample
Who is being recruted

Urogenital Diseases+5

+ Female Urogenital Diseases and Pregnancy Complications

+ Infections

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: July 2012
See protocol details

Summary

Principal SponsorNationwide Children's Hospital
Last updated: October 15, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorNationwide Children's Hospital
Last updated: October 15, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsInfectionsUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Tract InfectionsCatheter-Related Infections

Criteria

1 inclusion criteria required to participate
Patients with urinary catheters placed that will be getting them removed

1 exclusion criteria prevent from participating
Patient's currently getting treated for UTI

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Nationwide Children's Hospital

Columbus, United StatesOpen Nationwide Children's Hospital in Google Maps
CompletedOne Study Center