Bacteriuria Clinical Trial
Official title:
Bacteriuria Eradication Through Probiotics
Many children who catheterize their bladders because of spina bifida or other neurologic disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the gut which colonize the vagina and are carried into the bladder during catheter passage. We seek to test whether oral administration of probiotic bacteria can "displace" these vagina-derived uropathogens and reduce or prevent bacteriuria in girls with spina bifida who empty their bladders through catheterization.
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
urinary tract infections are common. Furthermore, this approach carries the potential for
deleterious side effects, and may promote the development of antibiotic-resistant bacteria.
Urinary tract infection in girls occurs 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 L. 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
Lactobacillus GG drinks had fewer episodes of UTI compared to those women not receiving
probiotics. A placebo-controlled study in premature infants also used L. rhamnosus 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 patients 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.
Our objective is to determine whether over the course of 3 months, probiotics can reduce
preexisting or new bacteriuria in girls with spina bifida who perform clean intermittent
catheterization for bladder emptying. We will also attempt to ascertain whether changes in
bacteriuria are associated with vaginal colonization by the administered probiotics.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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