Lactobacillus Probiotic for Prevention of UTI

NCT03151967 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY000001601R01DK088830-01A1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to see whether LACTIN-V (Lactobacillus crispatus CTV-05) is an effective method of preventing recurrent urinary tract infections (UTI's) and to learn the side effects of LACTIN-V. LACTIN-V is a vaginal applicator that contains Lactobacillus crispatus, an organism found naturally in the vaginas of healthy women. Lactobacillus bacteria are thought to help prevent other bacteria such as E. coli from causing UTI's. This is a double blind study comparing active product to a placebo (inactive vaginal applicator without any medicine).

Conditions

Urinary Tract Infections (UTI's)

Outcome Measures

Primary Outcomes (1)

• UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B).

  Symptomatic UTI : Comparison of the number (%) of subjects over the 16-week study period following randomization, with at least one symptomatic UTI (as defined above) in the 2 intervention groups

  Week 2-18

Secondary Outcomes (1)

• Parameter of Vaginal Colonization

  Weeks 0, 2, 6, 10, 14 and18

Study Arms (2)

Applicator with LACTIN-V Treatment

ACTIVE COMPARATOR

Vaginal applicator containing Lactobacillus crispatus CTV-05

Drug: Lactobacillus crispatus CTV-05

Applicator with Placebo

PLACEBO COMPARATOR

Inactive vaginal applicator without any drug

Drug: Placebo

Interventions

Lactobacillus crispatus CTV-05 DRUG

vaginal applicator with medium containing drug

Also known as: Lactin-V

Applicator with LACTIN-V Treatment

Placebo DRUG

vaginal applicator with medium containing no drug

Applicator with Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pre-menopausal women
• present with an acute, uncomplicated, culture confirmed UTI, defined as dysuria, urgency and/or frequency
• at least one previous medically diagnosed UTI in past 12 months
• using a reliable method of birth control ie: history of tubal ligation, male partner with vasectomy, steroidal contraception, Nuva-Ring, IUD, use of non spermicidal condoms or abstinence.
• can provide written consent
• can understand and read English

You may not qualify if:

• history of urogenital infection within the past 30 days, including: UTI, medically diagnosed vaginitis
• current symptoms suggestive of pyelonephritis (fever\>100.4, flank pain of costovertebral angle tenderness, nausea and vomiting
• history of functional or anatomic urologic abnormalities, urologic surgery of chronic urinary catheterization
• history of pyelonephritis within the past 6 months
• diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more occasions during previous six months
• known HIV infection of seropositivity
• investigational drug use within 30 days of enrollment visit or current participation in another clinical trial
• diabetes, other significant medical problem or intercurrent acute illness that in the Nurse Practitioner's and/or Principal 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 objective.
• At the randomization visit, has any of the following findings on pelvic or other physical examination:
• unable to visualize cervix
• clinically significant abnormalities, such as inflammation, erosion and/or petechiae (bleeding under the skin) of external genitalia, vaginal or cervix on visual examination
• clinically significant tenderness on bimanual examination during the pelvic examination
• evidence of vaginitis or a sexually-transmitted disease
• any diagnosis requiring antibiotics

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Hall Health Primary Care Center

Seattle, Washington, 98115, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Ann Stapleton, MD
• Organization: University of Washington

stapl@uw.edu

2066609981

Study Officials

• Ann E Stapleton, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine, Infectious Diseases

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: May 12, 2017
• Study Start: September 1, 2015
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)