Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection - Full Text View

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

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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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Osel, Inc.

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

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