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Probiotics for Girls With Recurring Urinary Tract Infections

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00789464
First received: November 10, 2008
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: H-23187: PROBIOTIC PROPHYLAXIS AGAINST RECURRENT PEDIATRIC URINARY TRACT INFECTION

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 Name: TMP/SMZ, Bactrim, Septra

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789464

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: David R. Roth, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: David R. Roth, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00789464     History of Changes
Other Study ID Numbers: H-23187
Study First Received: November 10, 2008
Last Updated: November 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Urinary Tract Infection
Probiotics
Dietary Supplements
Bacteriuria

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Sulfamethoxazole
Trimethoprim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013