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WITHDRAWN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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Page 1 of 1 (1 locations)

1

Texas Children's Hospital

Houston, Texas, United States, 77030