Probiotics in Girls With Spina Bifida
Probiotics in Girls With Spina Bifida
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.
In children with spina bifida and neurogenic bladder dysfunction, the need for intermittent
 bladder catheterization increases the risk of bacteriuria. In many patients, this leads to a
 clinically significant urinary tract infection (UTI). Many of these children are placed on
 long term, low dose antibiotic suppression to prevent recurrent urinary infection.
 Unfortunately, bacteriuria often persists despite daily antibiotic therapy, and breakthrough
 UTIs are common. Furthermore, this approach carries the potential for deleterious side
 effects, and may promote the development of antibiotic-resistant bacteria.

 UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and
 peri-urethral mucosa, thus gaining access to the bladder. In girls with spina bifida, access
 to the bladder is greatly facilitated by catheter passage. Antibiotic prophylaxis relies on
 maintaining a low dose of antibiotic in the urinary stream, which decreases peri-urethral
 colonization, and prevents proliferation of bacteria after they gain access to the bladder.
 An alternative approach to daily antibiotic prophylaxis is to decrease the risk of urinary
 colonization with virulent bacteria by supplementing the normal bacteria flora with
 non-infection causing strains of bacteria.

 Probiotics are dietary supplements containing potentially beneficial bacterial strains such
 as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in
 several studies over the last 30 years. Studies using Lactobacillus rhamnosus GG, a probiotic
 introduced in the late 1980s to alleviate diarrhea, have shown promising results when used
 for UTI prevention. In one study, researchers found that the subjects consuming GG drinks had
 fewer episodes of UTI compared to those women not receiving probiotics. A placebo-controlled
 study in premature infants also used GG in an attempt to prevent UTI. The number of urinary
 infections was reduced but statistically the difference was not significant. Finally, a
 recent randomized clinical trial demonstrated that the rate of UTI in children taking
 prophylactic antibiotics was similar to that of patients taking Lactobacillus acidophilus
 alone. The efficacy of probiotic usage in the spina bifida population has not been reported.

 Clinical trials have suggested that oral ingestion of the probiotic strains Lactobacillus
 reuteri RC-14 and Lactobacillus rhamnosus GR-1 results in vaginal colonization and prevention
 of adult UTI, potentially by inhibiting uropathogen ascension from the vagina to the urinary
 tract.

 A total of 60 patients will be enrolled for this pilot study, half of whom will be randomized
 to receive probiotics and the reminder of which will receive placebo [1:1 ratio; 50% chance
 of being in each group (A and B)]. Treatment assignment will be double blinded and will last
 6 months.
Inclusion Criteria:

 -  Girls

 -  Age 3 months to 18 years

 -  Spina bifida as a sole urologic diagnosis

 -  Informed consent and assent (7 years of age and older)

 Exclusion Criteria:

 -  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