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Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305227
First Posted: March 21, 2006
Last Update Posted: February 8, 2016
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.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Osel, Inc.
Information provided by (Responsible Party):
Ann Stapleton, University of Washington
  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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 Ann Stapleton, University of Washington:

Primary Outcome Measures:
  • Incidence of Urinary Tract Infection [ Time Frame: 10 weeks ]
    Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.


Secondary Outcome Measures:
  • Incidence of Vaginal Discharge [ Time Frame: 4 mo ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00305227


Locations
United States, Washington
Hall Health Primary Care Center, University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Osel, Inc.
Investigators
Principal Investigator: Ann E Stapleton, MD University of Washington
  More Information

Publications:

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
5P01DK053369 ( U.S. NIH Grant/Contract )
UW/LB-001
First Submitted: March 20, 2006
First Posted: March 21, 2006
Results First Submitted: June 3, 2014
Results First Posted: July 4, 2014
Last Update Posted: February 8, 2016
Last Verified: January 2016

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

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