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

描述（由申请人提供）：拟议的研究将调查细菌性阴道病的危险因素，并描述来自印度迈索尔育龄妇女的乳杆菌菌株和乳杆菌噬菌体的特征。利用已有的一项纳入750名育龄妇女的单纯疱疹2型感染前瞻性队列研究，我们将在一项探索性横断面研究中招募200名妇女，以调查印度迈索尔育龄妇女细菌性阴道病的危险因素，并在该人群中识别和表征乳杆菌和乳杆菌噬菌体。此外，我们将对20名妇女进行为期三个月的可行性亚研究，以确定我们是否可以直接从阴道菌群中等的妇女中分离噬菌体，并确定噬菌体类型分布是否随时间而变化。这是印度首次进行此类研究，将为验证噬菌体可能导致细菌性阴道病的假设奠定基础。本研究的目的是：1)收集印度迈索尔育龄妇女细菌性阴道病的危险因素和相关因素的信息；2)鉴定在印度迈索尔育龄妇女的阴道液中发现的乳杆菌种类；3)分析印度迈索尔育龄妇女阴道分泌液中阴道乳杆菌分离噬菌体的分布和类型；4)调查在阴道菌群中等的一小群妇女的阴道液中发现的噬菌体类型随时间的相对变化。拟议的研究以下列方式实现妇幼保健战略的目标：1)促进孕产妇和儿童健康方面的合作，并有助于全球了解孕产妇和儿童发病和死亡的原因。这项研究将促进向印度研究人员转让技术能力和培训；在细菌性阴道病具有高度公共卫生重要性的环境中建设基础设施，因为它会导致新生儿的死亡率和发病率；将急需的注意力集中在过去很少受到关注的情况上；并为印度和美国的研究人员更好地了解细菌性阴道病的流行病学、文化特异性风险因素和噬菌体在病因学中的作用提供机会；2)解决孕产妇、新生儿和儿科发病率和死亡率的主要原因；3)它侧重于MCHDR的“高优先级”领域：调查“不良出生结果的风险因素，包括低出生体重和宫内生长迟缓”。

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".