Lactobacillus Probiotic for Prevention of UTI

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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