Probiotics in Girls With Spina Bifida

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Urinary Tract Infection

In brief

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.

Key facts

Study ID

NCT00767988

Run by

Baylor College of Medicine

People needed

0

Last updated by the study team

2015-09-15

Who can join

Age: 0 and older, up to 17. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Girls
• Age 3 months to 18 years
• Spina bifida as a sole urologic diagnosis
• Informed consent and assent (7 years of age and older)

You may not qualify if…

• Males
• Females over 18 years and older
• Prophylactic antibiotics
• Immunosuppression from corticosteroids, transplant recipients or children with congenital immunodeficiencies
• Poorly controlled diabetes
• Untreated HIV infection
• Chronic indwelling catheters in the bladder
• Malnourished
• Pregnancy
• Any form of urinary division other than appendicovesicostomies is not permitted
• Bladder augmentation
• Unresolved reflux

Where it is running

• Texas Children's Hospital — Houston, Texas, United States
• Shriner's Childrens Hospital Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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