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Probiotics for Girls With Recurring Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00789464
Recruitment Status : Withdrawn (Withdrawn by PI)
First Posted : November 11, 2008
Last Update Posted : August 18, 2020
Information provided by (Responsible Party):
David Roth, Baylor College of Medicine

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

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Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Primary Outcome Measures :
  1. The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00789464

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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: David R. Roth, MD Baylor College of Medicine
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Responsible Party: David Roth, Professor, TCH Urology, Baylor College of Medicine Identifier: NCT00789464    
Other Study ID Numbers: H-23187
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Keywords provided by David Roth, Baylor College of Medicine:
Urinary Tract Infection
Dietary Supplements
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors