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Treatment and/or Prevention of Urinary Tract Infections (UTI)

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: NCT00801021
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : March 8, 2010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Information provided by:
Biomedical Development Corporation

Brief Summary:
The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.

Condition or disease Intervention/treatment Phase
Cystitis Urinary Tract Infections Drug: Frio Mouth Rinse Phase 1

Detailed Description:
A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment and/or Prevention of Urinary Tract Infections
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Frio Oral Rinse
Prescription Mouth Rinse
Drug: Frio Mouth Rinse
Rinse with 15ml twice daily then expectorate
Other Name: Prescription Mouth Rinse

Primary Outcome Measures :
  1. The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit. [ Time Frame: 7 to 10 Days ]

Secondary Outcome Measures :
  1. The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection) [ Time Frame: 28-35 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Non-pregnant adult females;
  2. 18 years of age or older;
  3. Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry;
  4. One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf.
  5. A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism

Exclusion Criteria:

  1. Males;
  2. Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
  3. Three or more episodes of acute uncomplicated UTI in the past 12 months;
  4. Known structural abnormality that would predispose the participant to reflux or urinary retention;
  5. Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder;
  6. Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV;
  7. Patients with onset of symptoms > 72 hours prior to entry;
  8. Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection;
  9. Patients with purported hypersensitivity to iodine;
  10. Patients with history of thyroid disease;
  11. Patients who received treatment with other antimicrobials within 48 hours prior to entry;
  12. Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse;
  13. Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of 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): NCT00801021

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United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomedical Development Corporation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
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Principal Investigator: Barbara W. Trautner, M.D., Ph.D. Baylor College of Medicine
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Responsible Party: Barbara Wells Trautner, M.D., Ph.D., Baylor College of Medicine Identifier: NCT00801021    
Other Study ID Numbers: H-23281
1R41DK082089-01 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: November 2009
Keywords provided by Biomedical Development Corporation:
Urinary Tract Infections
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Urinary Bladder Diseases