Probiotics for Girls With Recurring Urinary Tract Infections

Study Overview
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Brief Summary
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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.

Official Title
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H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection

Conditions
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Recurrent Urinary Tract Infection

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM 17938
* Drug: trimethoprim/sulfamethoxazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ARM A<br>Probiotics drops plus placebo elixir | Dietary Supplement: Lactobacillus reuteri DSM 17938<br>* DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.<br>|
| Other: ARM B<br>TMP/SMZ elixir plus placebo drops | Drug: trimethoprim/sulfamethoxazole<br>* Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.<br>* Other names: TMP/SMZ, Bactrim, Septra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Infection, Probiotics, Dietary Supplements, Bacteriuria