Probiotics for Girls With Recurring Urinary Tract Infections

Recurrent Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00789464
• Other study ID #: H-23187
• Status: Withdrawn
• Phase: Phase 2

Study information

• Verified date: August 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 3 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.		1 year