Status:
WITHDRAWN
Probiotics in Girls With Spina Bifida
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Shriners Hospitals for Children
Conditions:
Urinary Tract Infection
Eligibility:
FEMALE
3-17 years
Phase:
PHASE2
Brief Summary
Girls with spina bifida also have bladder problems. This is because they need temporary placement of a tube into the bladder to remove urine. This thin flexible tube is called a catheter. It can incre...
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
- Girls
- Age 3 months to 18 years
- Spina bifida as a sole urologic diagnosis
- Informed consent and assent (7 years of age and older)
Exclusion
- Males
- Females over 18 years and older
- Prophylactic antibiotics
- Immunosuppression from corticosteroids, transplant recipients or children with congenital immunodeficiencies
- Poorly controlled diabetes
- Untreated HIV infection
- Chronic indwelling catheters in the bladder
- Malnourished
- Pregnancy
- Any form of urinary division other than appendicovesicostomies is not permitted
- Bladder augmentation
- Unresolved reflux
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00767988
Last Update
September 15 2015
Active Locations (2)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030
2
Shriner's Childrens Hospital Houston
Houston, Texas, United States, 77077