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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00717600
Other study ID # H-21679
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received July 16, 2008
Last updated July 16, 2008
Start date January 2008
Est. completion date September 2008

Study information

Verified date July 2008
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Female
Age group N/A to 18 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Texas Children's Hospital Houston Texas

Sponsors (4)

Lead Sponsor Collaborator
Baylor College of Medicine Chr Hansen A/S, Lawson Health Research Institute, Texas Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary bacteriuria 3 months Yes
Secondary urinary tract infections 3 months Yes
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