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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  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

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

Investigators
Principal Investigator:     Walter E Stamm, MD     University of Washington    
  More Information

Publications:
Giorgi A, Torriani S, Dellaglio F, Bo G, Stola E, Bernuzzi L. Identification of vaginal lactobacilli from asymptomatic women. Microbiologica. 1987 Oct;10(4):377-84.
 
Antonio MA, Hawes SE, Hillier SL. The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis. 1999 Dec;180(6):1950-6.
 
Antonio MA, Hillier SL. DNA fingerprinting of Lactobacillus crispatus strain CTV-05 by repetitive element sequence-based PCR analysis in a pilot study of vaginal colonization. J Clin Microbiol. 2003 May;41(5):1881-7.
 
Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol. 2000 Nov;10(8):509-15.
 
Stamm WE, Counts GW, Wagner KF, Martin D, Gregory D, McKevitt M, Turck M, Holmes KK. Antimicrobial prophylaxis of recurrent urinary tract infections: a double-blind, placebo-controlled trial. Ann Intern Med. 1980 Jun;92(6):770-5.
 
Gupta K, Scholes D, Stamm WE. Increasing prevalence of antimicrobial resistance among uropathogens causing acute uncomplicated cystitis in women. JAMA. 1999 Feb 24;281(8):736-8.
 
Hooton TM, Scholes D, Gupta K, Stapleton AE, Roberts PL, Stamm WE. Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women: a randomized trial. JAMA. 2005 Feb 23;293(8):949-55.
 
Reid G, Bruce AW, Fraser N, Heinemann C, Owen J, Henning B. Oral probiotics can resolve urogenital infections. FEMS Immunol Med Microbiol. 2001 Feb;30(1):49-52.
 
Stamey TA, Sexton CC. The role of vaginal colonization with enterobacteriaceae in recurrent urinary infections. J Urol. 1975 Feb;113(2):214-7.
 
Gupta K, Stapleton AE, Hooton TM, Roberts PL, Fennell CL, Stamm WE. Inverse association of H2O2-producing lactobacilli and vaginal Escherichia coli colonization in women with recurrent urinary tract infections. J Infect Dis. 1998 Aug;178(2):446-50.
 
Hooton TM, Fihn SD, Johnson C, Roberts PL, Stamm WE. Association between bacterial vaginosis and acute cystitis in women using diaphragms. Arch Intern Med. 1989 Sep;149(9):1932-6.
 
Hooton TM, Roberts PL, Stamm WE. Effects of recent sexual activity and use of a diaphragm on the vaginal microflora. Clin Infect Dis. 1994 Aug;19(2):274-8.
 
Osset J, Bartolome RM, Garcia E, Andreu A. Assessment of the capacity of Lactobacillus to inhibit the growth of uropathogens and block their adhesion to vaginal epithelial cells. J Infect Dis. 2001 Feb 1;183(3):485-91. Epub 2000 Dec 29.
 

Responsible Party:   University of Washington ( Walter E Stamm )
Study ID Numbers:   DK53369, UW/LB-001, P01 DK 53369-06
First Received:   March 20, 2006
Last Updated:   June 19, 2008
ClinicalTrials.gov Identifier:   NCT00305227
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
urinary tract infection  
cystitis  
Lactobacillus  
probiotic  
prevention  

Study placed in the following topic categories:
Urologic Diseases
Urinary Tract Infections
Cystitis
Recurrence

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on September 05, 2008




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