BERP: Bacteriuria Eradication Through Probiotics

Sponsor

Baylor College of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT00717600

Collaborator

Chr Hansen (Industry), Lawson Health Research Institute (Other)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bacteriuria	Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bacteriuria Eradication Through Probiotics

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2008

Anticipated Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Oral probiotics	Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 2x10^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule. Other Names: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 (Urex cap-5 from CHR. Hansen), batch 2750558

Arm

Intervention/Treatment

Experimental: 1

Oral probiotics

Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1

2x10^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule.

Other Names:

Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 (Urex cap-5 from CHR. Hansen), batch 2750558

Outcome Measures

Primary Outcome Measures

bacteriuria [3 months]

Secondary Outcome Measures

urinary tract infections [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Eligible subjects are girls (age 3 months to 18 years) with spina bifida as a sole urologic diagnosis
perform clean intermittent catheterization because of neurogenic bladder.
Secondary vesicoureteral reflux is permissible.
Patients with appendicovesicostomies and no other forms of urinary diversion are permitted.

Exclusion Criteria:

Patients will be excluded if they are taking antibiotics
immunosuppressed, i.e., transplant recipients or children with congenital immunodeficiencies
poorly controlled diabetes
untreated HIV infection
immunosuppression from corticosteroids
malnutrition
pregnancy
chronic indwelling catheters in the bladder
any urinary diversion or bladder augmentation.