Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

NCT01696227 | Completed

• 1 other identifier: IRB12-00279
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent UTIs; Catheter-Related Infections

Keywords

Nissle 1917; Probiotic; Uropathogen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Nissle 1917 DRUG

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

Also known as: Probiotic, Mutaflor

Nissle 1917

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with urinary catheters that will be getting them removed

You may qualify if:

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

You may not qualify if:

• Patient's currently getting treated for UTI

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43206, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacteria recovered from samples will be retained

MeSH Terms

Conditions

Urinary Tract Infections; Catheter-Related Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Elizabeth J Lucas, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow MD

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (1)