Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection

This study has been completed.
Sponsor:
Collaborators:
Osel, Inc.
Information provided by (Responsible Party):
Ann Stapleton, University of Washington
ClinicalTrials.gov Identifier:
NCT00305227
First received: March 20, 2006
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Recurrent urinary tract infections (RUTIS) continue to be a major health problem in women and are now complicated by increasing antibiotic resistance. New preventive approaches are needed. Because most women with RUTI lack the normal protective Lactobacillus (LB) in their vaginal flora, we hypothesized that restoration of LB would reduce RUTIS. In this trail, women with recent UTI are randomized to receive either LB or placebo vaginal capsules and are followed for side effects, for colonization with LB and for occurrence of RUTI over hte next four months.


Condition Intervention Phase
Urinary Tract Infection
Drug: Lactin-V
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infections

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Incidence of Urinary Tract Infection [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.


Secondary Outcome Measures:
  • Incidence of Vaginal Discharge [ Time Frame: 4 mo ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: March 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactin-V
Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Drug: Lactin-V
Placebo Comparator: Placebo
Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Drug: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pre-menopausal woman aged 18-40 years
  • current symptomatic uncomplicated cystitis
  • cystitis is treated with trimethoprim-sulfamethoxazole (TMP-SMX)
  • completion of screening procedures
  • negative screening monolayer Pap smear or hysterectomy
  • history of at least two prior symptomatic UTI's treated within the past 12 months or one pior symptomatic UTI treated in the past six months
  • agree to return for the Randomization Visit (Visit 2)
  • regular menstrual cycles or amenorrheic due to use of a long acting progestin, continuous use of oral contraceptives or hysterectomy
  • willing to insert vaginal capsules without an applicator
  • capable of providing informed consent
  • able to read and understand English
  • agree to abstain from self-medication with antibiotics for UTI symptoms
  • agree to abstain from antibiotic prophylaxis for recurrent UTI
  • agree to abstain from the use of any other intra-vaginal product
  • agree to abstain from sexual intercourse for 24 hours after capsule insertion
  • agree to not use tampons for 24 hours after capsule insertion
  • agree to use an adequate method of birth control

Exclusion Criteria:

  • complicated cystitis or uncomplicated pyelonephritis.
  • cystitis at Visit 1 not treated with TMP-SMX
  • uropathogen resistant to TMP-SMX isolated at Visit 1 and persistent symptoms at Visit 2 or failure to achieve a significant reduction in urine wbc count at Visit 2
  • vaginal or cervical infection, currently or within the past 21 days, with bacterial vaginosis (treated, symptomatic infection), Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis or Herpes Simplex
  • symptomatic bacterial vaginosis at Visit 1
  • high risk for sexually transmitted diseases and/or HIV, including:

    1. diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more occasions during the previous six months;
    2. sexual intercourse with a homosexual/bisexual male in the last 10 years;
    3. sexual intercourse with an injection drug user or sex worker in the last 10 years; or
    4. shared needles for injected drugs in the last 10 years.
  • chronic vaginal, urinary or pelvic symptoms not attributable to UTI
  • recurrent bacterial vaginosis (three or more symptomatic, treated infections in the prior 12 months)
  • pregnancy or within two months of last pregnancy
  • lactation
  • antibiotic therapy fewer than three days prior to Randomization Visit
  • antifungal therapy fewer than seven days prior to the Randomization Visit
  • Antibiotics planned within four months
  • abnormal Pap smear requiring a procedure for diagnosis or treatment in the past 12 months
  • use of CTV-05 within one year of the Randomization Visit
  • menopause
  • use of a NuvaRing planned during the course of the study
  • any significant disease or acute illness that in the Investigator's assessment could complicate the evaluation
  • known HIV infection
  • immunosuppressive drug within 60 days
  • known allergy to any component of LACTIN-V or the placebo capsule
  • unavailable for follow-up visits
  • drug or alcohol abuse within past two years
  • any social or medical condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
  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 ClinicalTrials.gov identifier: NCT00305227

Locations
United States, Washington
Hall Health Primary Care Center, University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Osel, Inc.
Investigators
Principal Investigator: Ann E Stapleton, MD University of Washington
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ann Stapleton, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00305227     History of Changes
Other Study ID Numbers: 28552-B, R01DK055369, UW/LB-001, P01 DK 53369-06
Study First Received: March 20, 2006
Results First Received: June 3, 2014
Last Updated: June 3, 2014
Health Authority: Federal government: United States: Food and Drug Administration

Keywords provided by University of Washington:
urinary tract infection
cystitis
Lactobacillus
probiotic
prevention

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014