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Probiotics for Girls With Recurring Urinary Tract Infections

Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Urinary Tract Infection

Intervention: Lactobacillus reuteri DSM 17938 (Dietary Supplement); trimethoprim/sulfamethoxazole (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Baylor College of Medicine

Official(s) and/or principal investigator(s):
David R. Roth, MD, Principal Investigator, Affiliation: Baylor College of Medicine


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.

Clinical Details


Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.


Minimum age: 3 Months. Maximum age: 17 Years. Gender(s): Female.


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


- 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

Locations and Contacts

Texas Children's Hospital, Houston, Texas 77030, United States
Additional Information

Starting date: August 2009
Last updated: November 30, 2010

Page last updated: August 23, 2015

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