Probiotics for Girls With Recurring Urinary Tract Infections
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.
|Recurrent Urinary Tract Infection||Dietary Supplement: Lactobacillus reuteri DSM 17938 Drug: trimethoprim/sulfamethoxazole||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection|
- The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [ Time Frame: 1 year ]
Probiotics drops plus placebo elixir
Dietary Supplement: Lactobacillus reuteri DSM 17938
DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.
TMP/SMZ elixir plus placebo drops
Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.
Other Name: TMP/SMZ, Bactrim, Septra
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789464
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David R. Roth, MD||Baylor College of Medicine|