Recurrent Urinary Tract Infection
Conditions
Keywords
Urinary Tract Infection, Probiotics, Dietary Supplements, Bacteriuria
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 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri DSM 17938
DSM 17938 drops (10\^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.
Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
3 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. | 1 year |
Countries
United States
Outcome results
None listed