Probiotics for Girls With Recurring Urinary Tract Infections

Sponsor

Baylor College of Medicine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00789464

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Urinary Tract Infection	Dietary Supplement: Lactobacillus reuteri DSM 17938 Drug: trimethoprim/sulfamethoxazole	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection

Arms and Interventions

Arm	Intervention/Treatment
Other: ARM A 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.
Other: ARM B TMP/SMZ elixir plus placebo drops	Drug: trimethoprim/sulfamethoxazole Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year. Other Names: TMP/SMZ, Bactrim, Septra

Arm

Intervention/Treatment

Other: ARM A

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.

Other: ARM B

TMP/SMZ elixir plus placebo drops

Drug: trimethoprim/sulfamethoxazole

Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.

Other Names:

TMP/SMZ, Bactrim, Septra

Outcome Measures

Primary Outcome Measures

The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 17 Years

Sexes Eligible for Study:

Female

Accepts 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