Skip to main content
OpenTrials
Completed

NCT Number: NCT01696227

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient's currently getting treated for UTI

Treatment and study plan

Nissle 1917

Drug

Uropathogens will be challenged to share the same in vitro environment with Nissle 1917.

Other names: Probiotic, Mutaflor

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: Nissle 1917

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 28, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.