Vaginal Use of Lactobacillus crispatus in Women, Safety Trials
Location(s): United States
Phase IIa randomized, double blind, placebo-controlled, clinical trial of LACTIN-V at 2 x 10^9 cfu/dose versus placebo, administered vaginally with a pre-filled applicator once daily for five consecutive days followed by a weekly dose over 2 additional weeks after an initial standardized antibiotic treatment with 0.75% topical metronidazole (MetroGel). A single site will enroll 40 participants (30 randomized to LACTIN-V and 10 to placebo).
Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and rep-PCR.
Safety will be determined by comparing the incidence of adverse events and serious adverse events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical examination, pelvic examination with colposcopy and laboratory measurements. Tolerability will be measured by percentage of subjects who discontinue study product use due to overt adverse events and percentage of subjects who adhere to complete dosing schedule. Acceptability will be assessed via a standardized questionnaire and focus group discussions.