Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection

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Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection

This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), June 2008

Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Osel, Inc.

Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00305227

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 II

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infections

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
incidence of urinary tract infection [ Time Frame: 4 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
incidence of vaginal discharge [ Time Frame: 4 mo ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Intervention arm: Vaginal capsule containing Lactobacillus crispatis Drug: LACTIN-V
One vaginal capsule containing lactobacilli in high concentration
2: Placebo Comparator
placebo vaginal capsule Drug: placebo
vaginal capsule 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:

diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more occasions during the previous six months;
sexual intercourse with a homosexual/bisexual male in the last 10 years;
sexual intercourse with an injection drug user or sex worker in the last 10 years; or
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305227

Contacts

Contact: Niki DeShaw, RN (206) 685-1048 ndeshaw@u.washington.edu

Locations

United States, Washington
Hall Health Primary Care Center, University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Natalie Deshaw, RN 206-626-4170 ndeshaw@u.washington.edu
Principal Investigator: Walter E Stamm, MD
Sub-Investigator: Thomas M Hooton, MD
Sub-Investigator: Ann Stapleton, MD
Sub-Investigator: Christopher A Czaja, MD

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Osel, Inc.

Investigators

Principal Investigator: Walter E Stamm, MD University of Washington