Phase I Trial of aLactobacillus crispatusVaginal Suppository for Prevention of Recurrent Urinary Tract Infection in Women

Abstract

Objectives: We performed a phase I trial to assess the safety and tolerance of aLactobacillusvaginal suppository for prevention of recurrent UTI.Methods: Premenopausal women with a history of recurrent UTI were randomized to useL. crispatusCTV-05 or placebo vaginal suppositories daily for five days.Results: 30 women were randomized (15 toL. crispatusCTV-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 toL. crispatusCTV-05 developed pyuria without associated symptoms. Most women had high concentrations of vaginalH202-producing lactobacilli before randomization.L. crispatus,L. jensenii, andL. gasseriwere the most commonLactobacillusspecies identified, with stable prevalence over time.Conclusions:L. crispatusCTV-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.