Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Baylor College of Medicine
Information provided by:
Biomedical Development Corporation Identifier:
First received: December 2, 2008
Last updated: March 4, 2010
Last verified: November 2009

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 Intervention Phase
Urinary Tract Infections
Drug: Frio Mouth Rinse
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Treatment and/or Prevention of Urinary Tract Infections

Resource links provided by NLM:

Further study details as provided by Biomedical Development Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Enrollment: 3
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Frio Oral Rinse
Prescription Mouth Rinse
Drug: Frio Mouth Rinse
Rinse with 15ml twice daily then expectorate
Other Name: Prescription Mouth Rinse

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.


Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00801021

United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomedical Development Corporation
Baylor College of Medicine
Principal Investigator: Barbara W. Trautner, M.D., Ph.D. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Barbara Wells Trautner, M.D., Ph.D., Baylor College of Medicine Identifier: NCT00801021     History of Changes
Other Study ID Numbers: H-23281, 1R41DK082089-01
Study First Received: December 2, 2008
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomedical Development Corporation:
Urinary Tract Infections

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases processed this record on November 19, 2014