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Probiotics for Girls With Recurring Urinary Tract Infections

NCT00789464 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-08-18

No results posted yet for this study

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

  • Recurrent Urinary Tract Infection

Interventions

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • David R. Roth, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789464 on ClinicalTrials.gov