Trials / Withdrawn
WithdrawnNCT00789464
Probiotics for Girls With Recurring Urinary Tract Infections
H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- Female
- Age
- 3 Months – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lactobacillus reuteri DSM 17938 | DSM 17938 drops (10\^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year. |
| DRUG | trimethoprim/sulfamethoxazole | Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year. |
Timeline
- First posted
- 2008-11-11
- Last updated
- 2020-08-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00789464. Inclusion in this directory is not an endorsement.