Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis.

ABSTRACT:

Background

Bacterial vaginosis is a very common vaginal infection. The lack of endogenous lactobacilli and overgrowth of pathogens facilitate numerous gynecological complications.

Methods

A phase I dose-ranging safety trial tested the safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by vaginal applicator. Twelve healthy volunteers were enrolled in 3 blocks of 4 (5 x 10, 1 x 10, and 2 x 10 cfu/dose). Each block was randomized in a 3:1 ratio of active product to placebo. Participants used study product for 5 consecutive days, returned for follow-up on days 7 and 14, and had phone interviews on days 2 and 35.

Results

All 12 participants took 5 doses and completed study follow-up.Overall, 45 adverse events (AEs) occurred, o

SUBMITTER: Hemmerling A 

PROVIDER: S-EPMC2758081 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature