Joint U.S.-India Study of Lactobacillus and its Phages in Bacterial Vaginosis

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DESCRIPTION (provided by applicant): The proposed study will investigate risk factors for bacterial vaginosis in and characterize Lactobacillus strains and Lactobacillus phages from women of reproductive age in Mysore India. Taking advantage of an existing prospective cohort study of Herpes Simplex 2 infection that has enrolled 750 women of reproductive age, we will enroll 200 women in an exploratory cross-sectional study to investigate the risk factors for bacterial vaginosis among reproductive age women in Mysore, India, and identify and characterize Lactobacillus and Lactobacillus phages among this population. In addition we will carry out a feasibility sub- study following 20 women bimonthly for three months to determine if we can isolate phages directly from women with intermediate vaginal flora, and determine if phage type distribution changes over time in vaginal fluids. This study, the first of its kind ever to be conducted in India, will lay the foundation to test the hypothesis that bacteriophage might be responsible for causing bacterial vaginosis. The aims of the study are to: 1) Collect information about risk factors and correlates of bacterial vaginosis among a population of reproductive-age women in Mysore, India; 2) Identify the Lactobacillus species found in vaginal fluids of a population of reproductive-age women in Mysore, India; 3) Analyze the distribution and types of phages isolated from vaginal Lactobacillus found in vaginal fluids of a population of reproductive-age women in Mysore, India; 4) Investigate the relative change, over time, in phage types found in the vaginal fluids of a small subgroup of women identified as having intermediate vaginal flora. The proposed research addresses the goals of MCHDR in the following ways: 1) It facilitates collaboration on maternal and children's health and contributes to a global understanding of the causes of morbidity and mortality in mothers and children. The research will facilitate the transfer of technical capacity and training to Indian researchers; build infrastructure in a setting where bacterial vaginosis has high public health importance because of its contribution to mortality and morbidity among neonates; focus much needed attention on a condition that has received minimal attention in the past; and provide an opportunity for both Indian and U.S. investigators to better understand the epidemiology, culturally specific risk factors, and role of phages in the etiology of bacterial vaginosis; 2) It addresses a leading cause of maternal, neonatal, and pediatric morbidity and mortality and India and; 3) It focuses on a "high priority" area for MCHDR: investigating "the risk factors for adverse birth outcomes including low birth weight and intrauterine growth retardation".