Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis.
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, of which 31 (69%) were genitourinary (GU) AEs. GU AEs appeared evenly distributed between the 3 treatment blocks and between LACTIN-V and placebo arms. The most common GU AEs were vaginal discharge in 5 subjects (42%), abdominal pain in 4 subjects (33%), metrorrhagia in 4 subjects (33%), vulvovaginitis in 4 subjects (33%), vaginal candidiasis in 3 subjects (25%), and vaginal odor in 3 subjects (25%). Forty-one (91%) AEs were mild (grade 1) in severity. All 4 moderate AEs (grade 2) were unrelated to product use. No grade 3 or 4 AEs or serious adverse events (SAE) occurred. Laboratory parameters and colposcopy findings were within normal limits or clinically insignificant. The product was well-tolerated and accepted.


CONCLUSIONS
All 3 dose levels of LACTIN-V appeared to be safe and acceptable in healthy volunteers.
Hemmerling
Anke
A
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California-San Francisco, 50 Beale Street, San Francisco, CA 94105, USA. ahemmerling@globalhealth.ucsf.edu
Harrison
William
W
Schroeder
Adrienne
A
Park
Jeanna
J
Korn
Abner
A
Shiboski
Stephen
S
Cohen
Craig R
CR
D000282:Administration, Intravaginal; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007778:Lactobacillus; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000382:microbiology* / Q000517:prevention & control*