Feasibility Study of Probiotics for Growth Faltering

说明(申请人提供)：在断奶时发生的腹泻病和生长迟缓是重大的公共卫生问题。发展中国家每年有1000万名五岁以下儿童死亡，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，在断奶时会增加，并与纯母乳喂养辅以额外食物时腹泻疾病的发病率增加有关。许多中断营养不良和腹泻病循环的潜在干预措施对发展中国家的社区来说在经济上或技术上都是不可行的。拟议的项目包括一项研究，该研究将确定对婴儿断奶时在酸奶中给予的益生菌GG(LGG)进行随机双盲对照研究的可行性，作为对这一营养不良和腹泻周期的文化和经济上合适的干预措施。拟议的项目还将获得巴基斯坦贫民窟儿童断奶前后腹泻病和生长发育的发病率和严重性的初步背景数据，包括身高体重和年龄体重z得分。这项研究将考察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，这项研究建议研究断奶后每天在家中跟踪儿童的可行性，监测健康和营养状况，并在酸奶中给随机接受这一干预的一组婴儿服用LGG。可行性研究的主要结果是有能力收集关于巴基斯坦社区的营养、一般健康、神经发育状况以及腹泻疾病的比率和持续时间的所需数据。其他主要结果包括确定腹泻病和生长迟缓的背景率和严重程度，按年龄身高和年龄体重确定z分数，以及LGG缓解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被用来准备一项关于全面临床试验的建议，作为对这些儿童断奶时生长迟缓和腹泻疾病的干预。

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.