NCT00767988

Probiotics in Girls With Spina Bifida

Withdrawn Phase 2 Last updated 15 September 2015

What this trial tests

Phase 2 trial testing Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1) in Urinary Tract Infection. Withdrawn.

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Sites	2 locations across United States

Drugs / interventions tested

• Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)
• Placebo

Conditions studied

• Urinary Tract Infection — all drugs for Urinary Tract Infection →

Sponsor

Baylor College of Medicine

Who can join

Adults 3 Months to 17, female only, with Urinary Tract Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Girls with spina bifida also have bladder problems. This is because they need temporary placement of a tube into the bladder to remove urine. This thin flexible tube is called a catheter. It can increase the risk of having bacteria in the urine. This in turn can lead to urinary tract infection (UTI).

Some girls with spina bifida are given antibiotics. These are medicines used to treat infections caused by bacteria. The medicine is used to prevent UTI. However, long-term treatment with these medicines can have side effects. For example, the bacteria may become resistant to the antibiotics. Also, bacteria in the urine can persist. UTI can still occur in patients on antibiotics.

UTI in girls occurs because bacteria migrate from the rectum to the vagina area. This gives the bacteria access to the bladder. Also, in girls with spina bifida, the access to the bladder is easier because of the catheter.

Probiotics are friendly bacteria. They are available as dietary supplements and as food. They contain helpful bacteria. Yogurt is an example of a food that contains probiotics.

The purpose of this study is to find out, if probiotics taken for 6 months can prevent UTI in girls with spina bifida. We will also try to find out whether changes in urine bacteria are associated with the taking of the probiotics. A vaginal and rectal swab will also be done to find out if taking probiotics has any benefits on preventing bacteria.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Probiotics for preventing urinary tract infection in people with neuropathic bladder.
   Toh SL, Boswell-Ruys CL, Lee BSB, Simpson JM, et al · · 2017 · cited 20× · PMID 28884476 · DOI 10.1002/14651858.cd010723.pub2