Phase I trial of a Lactobacillus crispatus vaginal suppository for prevention of recurrent urinary tract infection in women.
OBJECTIVE
We performed a phase I trial to assess the safety and tolerance of a Lactobacillus vaginal suppository for prevention of recurrent UTI.


METHODS
Premenopausal women with a history of recurrent UTI were randomized to use L. crispatus CTV-05 or placebo vaginal suppositories daily for five days.


RESULTS
30 women were randomized (15 to L. crispatus CTV-05). No severe adverse events occurred. Mild to moderate vaginal discharge and genital irritation were reported by women in both study arms. Seven women randomized to L. crispatus CTV-05 developed pyuria without associated symptoms. Most women had high concentrations of vaginal H202-producing lactobacilli before randomization. L. crispatus, L. jensenii, and L. gasseri were the most common Lactobacillus species identified, with stable prevalence over time.


CONCLUSIONS
L. crispatus CTV-05 can be given as a vaginal suppository with minimal sideeffects to healthy women with a history of recurrent UTI. Mild inflammation of the urinary tract was noted in some women.
Czaja
Christopher A
CA
Division of Allergy and Infectious Diseases, University of Washington School of Medicine, Seattle, WA 98195, USA. czajac@njc.org
Stapleton
Ann E
AE
Yarova-Yarovaya
Yuliya
Y
Stamm
Walter E
WE
D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D007778:Lactobacillus; D019936:Probiotics / Q000008:administration & dosage*; D055502:Secondary Prevention; D013488:Suppositories; D014552:Urinary Tract Infections / Q000188:drug therapy*; D014621:Vagina / Q000382:microbiology*
D013488:Suppositories