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

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

Lactobacillus Intravaginal
Lactobacillus Intravaginal
Lactobacillus_intravaginal(2).pdf
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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 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 side effects to healthy women with a history of recurrent UTI. Mild inflammation of the urinary tract was noted in some women.

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