Feasibility Study of Probiotics for Growth Faltering

描述（由申请人提供）：断奶时发生的腹泻病和生长迟缓是重大的公共卫生问题。在发展中国家，每年有1 000万5岁以下儿童死亡，其中一半以上与营养不良有关。暴露于环境中的污染物是一种风险，在断奶时增加，并且当纯母乳喂养补充其他食物时，与腹泻病发病率增加有关。对于发展中国家的社区来说，许多中断这种营养不良和腹泻疾病循环的潜在干预措施在经济上或技术上都不可行。拟议的项目包括一项研究，该研究将确定进行一项随机双盲对照研究的可行性，该研究将益生菌乳酸杆菌GG （LGG）添加到断奶婴儿的酸奶中，作为对这种营养不良和腹泻循环的文化和经济上适当的干预措施。拟议的项目还将获得有关巴基斯坦贫民窟社区儿童断奶前后腹泻病发病率和严重程度以及身高体重和体重年龄分数增长迟缓的初步背景数据。本研究将检验在婴儿出生时登记的可行性，每周在家中跟踪他们直到断奶，并测试识别断奶时间的能力。此外，本研究提出检验在断奶后每天在家跟踪儿童的可行性，以监测健康和营养状况，并对随机分组的婴儿进行酸奶中添加LGG的干预。可行性研究的主要成果是能够收集有关巴基斯坦社区营养、一般健康、神经发育状况以及腹泻发病率和持续时间的必要数据。其他主要结局包括确定腹泻病的背景率和严重程度，以及年龄的身高和体重对年龄的影响，以及LGG改善腹泻病和生长迟缓的初步能力。这些数据将与获得的可行性数据一起用于准备一项关于LGG作为这些儿童断奶时生长迟缓和腹泻疾病干预措施的全面临床试验提案。

DESCRIPTION (provided by applicant): Diarrheal disease and growth faltering that occur at the time of weaning are significant public health problems. Malnutrition is associated with more than half of the 10 million deaths per year in children under the age of five in the developing world. Exposure to contaminants in the environment is a risk that increases at the time of weaning and is linked to an increased incidence of diarrheal disease when exclusive breast feeding is supplemented by additional foods. Many of the potential interventions for interrupting this cycle of malnutrition and diarrheal disease are not economically or technically feasible for communities in the developing world. The proposed project consists of a study that will determine the feasibility of conducting a randomized-double blinded controlled study of the probiotic Lactobacillus GG (LGG) given in yogurt to infants at the time of weaning as a culturally and economically appropriate intervention for this cycle of malnutrition and diarrhea. The proposed project will also obtain preliminary, background data on the incidence and severity of both diarrheal disease and growth faltering by weight for height and weight for age z scores before and after the time of weaning in children in a slum community in Pakistan. This study will examine the feasibility of enrolling infants at birth, following them weekly at home until the time of weaning and testing the ability to identify the time of weaning. Further, this study proposes to examine the feasibility of following children daily at home after weaning, to monitor health and nutritional status and to administer LGG in yogurt to a group of infants randomized to this intervention. The primary outcomes for the feasibility study are the ability to collect the required data on nutritional, general health, neuro-developmental status, and on the rate and duration of diarrheal disease in the community in Pakistan. Additional primary outcomes include the determination of the background rates and severity of diarrheal disease and growth faltering by height for age and weight for age z scores and the preliminary ability of LGG to ameloriate both diarrheal disease and growth faltering. These data will be used, with the feasibility data obtained, to prepare a proposal for a full clinical trial of LGG as an intervention for growth faltering and diarrheal disease at the time of weaning in these children.