Status:
WITHDRAWN
Probiotics for Girls With Recurring Urinary Tract Infections
Lead Sponsor:
Baylor College of Medicine
Conditions:
Recurrent Urinary Tract Infection
Eligibility:
FEMALE
3-17 years
Phase:
PHASE2
Brief Summary
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studi...
Eligibility Criteria
Inclusion
- Girls age 1 through age 17 years of age
- Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
- Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.
Exclusion
- Breastfeeding
- Pregnancy
- Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
- Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
- Poorly controlled diabetes
- Untreated HIV infection
- Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
- Malnutrition
- Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
- Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
- Patients with known anemia will be excluded from the study
- Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
- Patients taking other probiotics will be excluded from the study
- Patients already taking prophylactic antibiotics will be excluded from the study
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00789464
Last Update
August 18 2020
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030