Abstract
Bacterial vaginosis (BV), a condition affecting millions of women each year, is primarily caused by the gram-variable organism Gardnerella vaginalis. A number of organisms associated with BV cases have been reported to develop multidrug resistance, leading to the need for alternative therapies. Previously, we reported the antimicrobial peptide subtilosin has proven antimicrobial activity against G. vaginalis, but not against the tested healthy vaginal microbiota of lactobacilli. After conducting tissue sensitivity assays using an ectocervical tissue model, we determined that human cells remained viable after prolonged exposures to partially-purified subtilosin, indicating the compound is safe for human use. Subtilosin was shown to eliminate the motility and forward progression of human spermatozoa in a dose-dependent manner, and can therefore be considered a general spermicidal agent. These results suggest subtilosin would be a valuable component in topical personal care products aimed at contraception and BV prophylaxis and treatment.
Highlights
Subtilosin is a ribosomally-synthesized cyclopeptide produced by Bacillus subtilis ATCC 6633 and a recently identified natural isolate of Bacillus amyloliquefaciens [1, 2]
Data from human vaginal cell viability assays convincingly demonstrated the safety of subtilosin for human applications in comparison to other accepted and available products, indicating it could be safely incorporated into personal care applications aimed at the treatment of bacterial vaginosis
Prior research in our laboratory that involved similar studies with the EpiVaginal model was carried out in conjunction with in vivo testing of the rabbit vaginal irritation (RVI) system, which doubly confirmed the safety of another antimicrobial peptide, Lactocin 160 [29]
Summary
Subtilosin is a ribosomally-synthesized cyclopeptide produced by Bacillus subtilis ATCC 6633 and a recently identified natural isolate of Bacillus amyloliquefaciens [1, 2] This protein has a unique structure among bacteriocins [3], and possesses antimicrobial activity against a variety of pathogenic organisms, including Gardnerella vaginalis, Listeria monocytogenes, and Streptococcus agalactiae (Group B Streptococcus) [2]. The treatments recommended by the Centers for Disease Control (CDC) are clindamycin and metronidazole administered either orally or intravaginally [17] Following these guidelines successfully treats 60% of BV cases, but 20% of these cases return with highly developed antibiotic resistances [18,19,20]. It would be extremely desirable to have an alternative form of treatment that could fully eradicate the infection
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