Probiotics for Girls With Recurring Urinary Tract Infections

Baylor College of Medicine

Status and phase

Withdrawn

Phase 2

Conditions

Recurrent Urinary Tract Infection

Treatments

Dietary Supplement: Lactobacillus reuteri DSM 17938

Drug: trimethoprim/sulfamethoxazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00789464

H-23187

Details and patient eligibility

About

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.

Sex

Female

Ages

3 months to 17 years old

Volunteers

No Healthy Volunteers

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