BACKGROUND

Mounting evidence indicates that cells lining the lower female reproductive tract (LRT), including that of the vulva, vagina and external cervix, together with the resident commensal, vaginotropic microbiome (collectively, the “vaginal ecosystem”), form a dynamic organ that not only protects against infectious disease but also maintains tissue health and facilitates reproduction. The vaginal ecosystem is made up of a variety of factors that together act to support homeostasis of this ecosystem, including immune active cells, a protective mucus coating, a variety of antimicrobial peptides, and symbiotic bacteria (e.g., Lactobacilli).

To maintain homeostasis, the vaginal ecosystem must adapt to changes that occur during a woman's monthly hormone cycle, as well as adjust to more profound changes that happen at different times in the arc of a woman's life, such as puberty, reproductive years, and menopause. For example, during various stages of a woman's reproductive cycle, the vaginal ecosystem is continually providing a protective barrier to disease while at the same time lubricating the vagina to accommodate for sexual intercourse, or facilitating the passage of blood out of the uterus at menses, or inhibiting/optimizing sperm transport through the vagina and cervix, or undergoing chemical changes to promote labor and birth of a baby.

Throughout a woman's life, the LRT and vaginal ecosystem continually experience various disturbances (acute and chronic) caused by human behavior (e.g., sexual intercourse), but also by the use of contraception and vaginal products (Hickey et al.,Transl. Res.160:267, 2012; Ma et al.,Annu. Rev. Microbiol.66:371, 2012). If disturbance of the vaginal ecosystem becomes chronic, then discomfort, and even disease, can ensue. Any vaginal product that alters the mucosal environment and impairs the epithelial barrier may increase the severity of symptoms or risk of disease (Fichorova et al.,Toxicol. Appl. Pharmacol.285:198, 2015; Ma et al., 2012).

The consequence of products for women's health that ignores the full biology of the LRT and the vaginal ecosystem has been costly at both the epidemiologic and personal level. Vaginal products developed to prevent Sexually Transmitted Diseases (STDs) were actually found to cause an increase in STD rates when tested in clinical trials (Gali et al.,Antimicrob. Agents Chemother.54:5105, 2010; Dezzutti et al.,PLoS One7:e48328, 2012). Cell toxicity of various ingredients (some are referred to as “inactive carriers”) in vaginally applied products, for both the healthy vaginotropic bacteria and the vaginal mucosal epithelial cells, is pervasive and is evident at concentrations below those found in common vaginal products.

Safer LRT product compositions to aid in women's health are needed, such as products designed to preserve and support the vaginal ecosystem homeostasis and healthy function thereof. Presently disclosed embodiments address this need and provide other related advantages.

