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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00717600 |
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Date of registration:
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16/07/2008 |
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Primary sponsor: |
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Public title:
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Bacteriuria Eradication Through Probiotics
BERP |
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Scientific title:
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Bacteriuria Eradication Through Probiotics |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00717600 |
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Study type:
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Interventional |
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Study design:
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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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Countries of recruitment
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United States
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Contacts
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Name:
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Eric A Jones, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas Children's Hospital, Baylor College of Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bacteriuria
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Intervention(s)
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Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1
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Primary Outcome(s)
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bacteriuria
[Time Frame: 3 months]
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Secondary Outcome(s)
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urinary tract infections
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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