Probiotics for Girls With Recurring Urinary Tract Infections
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Urinary Tract Infection
Intervention: Lactobacillus reuteri DSM 17938 (Dietary Supplement); trimethoprim/sulfamethoxazole (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s):
David R. Roth, MD, Principal Investigator, Affiliation: Baylor College of Medicine
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 studies using adults over the last 30 years. Very few studies have been
conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum
and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder.
This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics +
placebo) to determine if UTIs are decreased when the probiotics are given.
Clinical Details
Official title: H-23187: PROBIOTIC PROPHYLAXIS AGAINST RECURRENT PEDIATRIC URINARY TRACT INFECTION
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
Eligibility
Minimum age: 3 Months.
Maximum age: 17 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Texas Children's Hospital, Houston, Texas 77030, United States
Additional Information
Starting date: August 2009
Last updated: November 30, 2010
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