Factors Influencing the Vaginal Microbiome and its Impact on Feminine Health and Wellness

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1 Factors Influencing the Vaginal Microbiome and its Impact on Feminine Health and Wellness Lindsay Peed, Ph.D. Cindy Korir-Morrison, Ph.D. Rebecca Vongsa, Ph.D. David Koenig, Ph.D. Corporate Research & Engineering, Kimberly-Clark Corp, Roswell, GA and Neenah, WI

2 Agenda Intro to Healthy vaginal microbiome Dysbiotic vaginal microbiome Factors associated with vaginal microbiome imbalance Restoring a healthy microbiome probiotics Restoring a healthy microbiome prebiotics

3 Kimberly-Clark: Our Business Personal Care Consumer Tissue K-C Professional

4 Kimberly-Clark: Our Vision Lead the world in essentials for a better life

5 Healthy Vaginal Microbiome The vulva and vagina are colonized by a rich and delicate community of bacteria or microflora Healthy = lactobacilli dominate member First line of defense against infection and disease Healthy microbiome protects against disease

6 Vaginal Community Structure Group I- L. crispatus Group II- L. gasseri Group III- L. iners Group IV- Diverse Group V- L. jensenii II I III V IV 73% of vaginal communities were dominated by one or more species of Lactobacillus Ravel et al. PNAS 2011

7 Common Types of Vaginal Infections Bacterial vaginosis Most frequently cited cause of vaginal discharge and malodor Associated with reduced lactobacilli predominance Nugent score used for diagnosis Associated with increased ph Yeast infections Symptoms include itching, soreness and burning Caused by Candida albicans Trichomoniasis Can be asymptomatic or include itching, malodor, burning and discharge Caused by Trichomonas vaginalis

8 Vaginal microbiome imbalance Factors associated with vaginal microbiome imbalance include: Age Menstruation status Body mass index Urinary incontinence Vaginal dryness Antibiotic usage Birth control methods Pregnancy

9 Community Dysbiosis When the community becomes imbalanced, it can lead to illness and discomfort microflora Healthy state BMI age external challenge Unhealthy state Vaginal epithelium HEALTHY UNHEALTHY change in homeostasis

10 Age and the Vaginal/Vulva Microbiome Clinical Study: Group 1 (18-22 yrs) Group 2 (23-48 yrs) Group 3 ( 49 yrs pre-menopausal) Group 4 ( 49 yrs post-menopausal) Group 1, 2, 3 Group 4 PCoA analysis confirms results younger older younger older Vongsa et al. Exploring Human Host-Microbiome Interactions in Health and Disease 2015

11 BMI and the Vulva Microbiome Body mass index (BMI) of and >30 Table 1. ph of exposed skin and labia. site BMI Mean Std. deviation Sum of ranks Mean of ranks Groups exposed abdominal skin labia majora high A normal AB high A normal B Vongsa et al. Exploring Human Host-Microbiome Interactions in Health and Disease 2013

12 Urinary Incontinence and the Vaginal/Vulva Microbiome in Postmenopausal Women Incontinence impacts vaginal and vulvar microbiome compositions in general Impact of incontinence more significant on vaginal microbiome than vulvar microbiome Li et al. ASM 2014

13 Vaginal Dryness and Microbiome Inverse correlation between vaginal dryness and Lactobacillus ratio Increased bacterial diversity in women experiencing moderate to severe vaginal dryness Microbiota profiles for 32 post-menopausal women clustered by biota similarity Hummelen et al. PLoS ONE 2011

14 Restoring a Healthy Microbiome microflora Vaginal epithelium Vaginal Probiotic/ Prebiotic?? Affect on host Pre-menopause Post-menopause

15 Probiotics Probiotics are live micro-organisms that can provide a health benefit in adequate amounts Some products currently in the market Examples include Bifidobacterium bifidum and Lactobacillus acidophilus in the gut vaginal gut skin

16 % abundance Probiotics Empower the Vaginal Biome Statistical increase in the abundance of lactobacilli based on 16S data Statistical decrease in abundance of bacteria associated with BV Atopobium Lactobacillus Gardnerella placebo probiotic Bisanz et al. PLoS ONE 2014 Days (increasing)

17 Prebiotics Prebiotics are ingredients that stimulate the growth or activity of microorganisms that contribute to the wellbeing of their host Examples include fructooligosaccharides (FOS) and glucooligosaccharides (GOS) carbohydrates Some products currently in the market vaginal gut skin

18 Prebiotics Improve Recovery Prebiotic treatment improved recovery to a normal vaginal flora after the treatment of a BV episode Coste et al., Obstet Gynecol Int. 2012

19 Developing an Ideal Solution Ideal prebiotic Selectively feeds your beneficial microbes Delivered directly to location of interest Non-toxic Non-mutagenic Not temperature sensitive Not ph sensitive Ideal probiotic Functional member of healthy normal flora Delivered directly to location of interest Survive journey to site of interest Low risk of becoming pathogenic Appropriate dosage for site

20 The Future of Pro/Prebiotics in Personal Care Products: Hurdles to Overcome Lack of scientific evidence and clinical studies for specific health applications Lack of data on safety, e.g long-term impact of probiotic organisms on existing microbiome and overall health Challenging regulatory requirements in marketing Products may fall into different product categories (cosmetics, drugs, medical devices, and dietary supplements) Worldwide variations in regulatory framework Balancing technical constraints vs consumer acceptability Not one size fits all Route of application- e.g. oral vs vaginal Product type- e.g. suppository vs gel/cream vs other Storage- refrigerated vs shelf-stable Huang & Tang Microbiology Discovery 2015

21 Questions?