Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

Catheter-Related Infections Clinical Trial

— Nissle 1917  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696227
• Other study ID #: IRB12-00279
• Status: Completed
• Phase: N/A
• First received: September 26, 2012
• Last updated: October 13, 2014
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Nationwide Children's Hospital IRB
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient's currently getting treated for UTI

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter-Related Infections
• Recurrent UTIs
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of Nissle 1917 to adversely affect the growth in vitro of identified uropathogens	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.	2 years	No