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Objectives : 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 vaginalH  2    0  2-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.

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