Abstract
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 vaginal