Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children (Nissle 1917)

This study is currently recruiting participants.
Verified September 2012 by Nationwide Children's Hospital
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Elizabeth Lucas, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01696227
First received: September 26, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Recurrent UTIs
Catheter-Related Infections
Drug: Nissle 1917

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Targeted Pathogen Replacement With Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Bacteria recovered from samples will be retained


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nissle 1917
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.
Other Names:
  • Probiotic
  • Mutaflor

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with urinary catheters that will be getting them removed

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient's currently getting treated for UTI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696227

Contacts
Contact: Elizabeth J Lucas, MD 614-722-2000 elizabeth.lucas@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43206
Contact: Elizabeth J Lucas, MD       elizabeth.lucas@nationwidechildrens.org   
Principal Investigator: Elizabeth J Lucas, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
Thrasher Research Fund
Investigators
Principal Investigator: Elizabeth J Lucas, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Elizabeth Lucas, Fellow MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01696227     History of Changes
Other Study ID Numbers: IRB12-00279
Study First Received: September 26, 2012
Last Updated: September 27, 2012
Health Authority: United States: Nationwide Children's Hospital IRB

Keywords provided by Nationwide Children's Hospital:
Nissle 1917
Probiotic
Uropathogen

Additional relevant MeSH terms:
Urinary Tract Infections
Catheter-Related Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on April 14, 2014