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

描述（由申请方提供）：拟定研究将调查印度迈索尔育龄妇女中细菌性阴道病的风险因素，并对乳杆菌菌株和乳杆菌属进行表征。利用现有的单纯疱疹病毒2型感染的前瞻性队列研究，该研究已招募了750名育龄妇女，我们将招募200名妇女进行探索性横断面研究，以调查印度迈索尔育龄妇女细菌性阴道病的危险因素，并确定和表征该人群中的乳杆菌和乳杆菌。此外，我们将进行可行性子研究，每两个月对20名妇女进行一次为期三个月的跟踪，以确定我们是否可以直接从具有中间阴道植物群的妇女中分离噬菌体，并确定阴道液中噬菌体类型分布是否随时间变化。这项研究是印度首次进行的此类研究，将为检验噬菌体可能导致细菌性阴道病的假设奠定基础。该研究的目的是：1）收集印度迈索尔育龄妇女人群中细菌性阴道病的危险因素和相关因素的信息; 2）确定印度迈索尔育龄妇女人群阴道液中发现的乳杆菌属; 3）分析从Mysore的育龄妇女群体的阴道液中发现的阴道乳杆菌中分离的细菌的分布和类型，印度的; 4）研究在鉴定为具有中间阴道植物群的一小组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《妇幼健康和发展战略》的目标：1）促进妇幼保健方面的合作，并有助于全球了解妇幼发病和死亡的原因。这项研究将促进向印度研究人员转让技术能力和培训;在细菌性阴道病对公共卫生具有高度重要性的环境中建立基础设施，因为它会导致新生儿的死亡率和发病率;将迫切需要的注意力集中在过去很少受到关注的一种疾病上;并为印度和美国的研究人员提供了一个机会，以更好地了解流行病学，文化特异性风险因素，以及细菌性阴道病的病原学中的作用; 2）它解决了产妇、新生儿和儿童发病率和死亡率的主要原因，并在印度和; 3）它侧重于MCHDR的“高度优先”领域：调查“不良出生结果的风险因素，包括出生体重低和宫内发育迟缓”。

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".