Randomonized controlled trial-lactoferrin prevention of diarrhea in children

随机对照试验——乳铁蛋白预防儿童腹泻

• 批准号: 7616234
• 负责人: THOMAS George CLEARY
• 金额: $ 23.99万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-29 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7616234
• 关键词: Address; Adverse effects; Age-Months; Animal Model; Anti-Bacterial Agents; Anti-Inflammatory Agents; Anti-inflammatory; Breast Feeding; Caring; Cattle; Cell surface; Cells; Child; Child health care; Childhood; Clinical Trials; Communities; Dairy Products; Data; Diarrhea; Disease; Enrollment; Frequencies; Gastroenteritis; Growth; Growth and Development function; Health; Health Benefit; Human; Human Milk; In Vitro; Infant; Infection; Ingestion; Intestines; Iron-Binding Proteins; Lactoferrin; Learning; Life; Literature; Malnutrition; Measures; Milk; Milk Proteins; Monitor; Participant; Peru; Physiological; Placebos; Populations at Risk; Prevention; Proteins; Randomized; Relative (related person); Research Personnel; Role; Structure; Supplementation; Virulence; Weaning; Work; antimicrobial; base; control trial; double-blind placebo controlled trial; functional food; improved; insight; iron metabolism; maltodextrin; programs; trial comparing

DESCRIPTION (provided by applicant): Much has been learned in recent years about the mechanisms by which breastfeeding improves child health and survival. However, there has been little progress in using these insights to improve pediatric care. Factors that are important for protecting the breast fed infant might be expected to decrease the adverse effects of weaning on diarrhea, growth, and development. The proposed study is meant to begin addressing this important gap by a clinical trial of lactoferrin supplementation in previously weaned children. Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those consumed if the child were still breast fed) will improve health by mimicking its protective roles in milk. There is a vast literature showing in vitro and animal model benefits of lactoferrin. For the last 27 years we have been working on understanding the protective factors in milk. Our recent studies have focused on lactoferrin. We have found that lactoferrin not only inhibits growth; it impairs virulence by causing loss of attachment/invasion structures in multiple bacterial enteropathogens. The proposed community-based study will be conducted in a previously weaned population at risk for repeated intestinal infections. Infants who are 12-24 months of age living in the District of Independencia, Lima, Peru will be eligible for enrollment. We will conduct a randomized double blind placebo controlled trial comparing twice daily supplementation with bovine lactoferrin versus a placebo (maltodextrin). Therapy will be continued for 12 months with close monitoring of all study participants for diarrhea and growth. Specific aim 1: Determine the effect of bovine lactoferrin supplementation on prevention of diarrhea, measured by the number of episodes of diarrhea during a 12 month trial in previously weaned Peruvian children enrolled at 12 to 24 months of age. Specific aim 2: Determine the effect of bovine lactoferrin supplementation on growth. The significance of these studies is that they will prove feasibility of improving child health after the end of breastfeeding by continuing ingestion of a major protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may be amenable to this approach.

描述（由申请人提供）：近年来，人们对母乳喂养改善儿童健康和生存的机制有了很多了解。然而，在使用这些见解来改善儿科护理方面进展甚微。保护母乳喂养婴儿的重要因素可能会减少断奶对腹泻、生长和发育的不良影响。拟议的研究是为了开始解决这一重要的差距，通过临床试验补充乳铁蛋白在以前断奶的儿童。乳铁蛋白是哺乳动物乳汁中最重要的蛋白质之一，是一种具有抗菌、抗炎、免疫调节等多种生理功能的铁结合蛋白。我们的假设是，乳铁蛋白（作为每日补充剂，其量与母乳喂养的儿童的摄入量相似）将通过模仿其在牛奶中的保护作用来改善健康。有大量文献显示乳铁蛋白的体外和动物模型益处。在过去的27年里，我们一直致力于了解牛奶中的保护因素。我们最近的研究集中在乳铁蛋白。我们已经发现，乳铁蛋白不仅抑制生长，它损害的毒力，造成损失的附着/入侵结构在多种细菌肠道病原体。拟议的基于社区的研究将在先前断奶的重复肠道感染风险人群中进行。居住在秘鲁利马独立区的12-24个月大的婴儿将有资格入组。我们将进行一项随机双盲安慰剂对照试验，比较每天两次补充牛乳铁蛋白与安慰剂（麦芽糊精）。治疗将持续12个月，密切监测所有研究参与者的腹泻和生长情况。具体目标1：确定补充牛乳铁蛋白对预防腹泻的影响，通过在12个月至24个月大的先前断奶的秘鲁儿童中进行的12个月试验期间腹泻发作次数进行测量。具体目标2：确定补充牛乳铁蛋白对生长的影响。这些研究的意义在于，它们将证明在母乳喂养结束后，通过继续摄入一种主要的保护性乳蛋白来改善儿童健康的可行性。断奶后腹泻和营养不良是一个全球性问题，可能适用于这种方法。