Status:
UNKNOWN
Bacteriuria Eradication Through Probiotics
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Chr Hansen
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Bacteriuria
Eligibility:
FEMALE
Up to 18 years
Phase:
PHASE1
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 t...
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 sign...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00717600
Start Date
January 1 2008
End Date
September 1 2008
Last Update
July 17 2008
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030