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Phase I Trial of a Lactobacillus crispatus Vaginal Suppository for Prevention of Recurrent Urinary Tract Infection in Women

2007; Hindawi Publishing Corporation; Volume: 2007; Linguagem: Inglês

10.1155/2007/35387

1098-0997

Christopher A. Czaja, Ann E. Stapleton, Yuliya Yarova‐Yarovaya, Walter E. Stamm,

Pediatric Urology and Nephrology Studies

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 H 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.