CORE--CLINICAL

核心--临床

• 批准号: 6588844
• 负责人: GUILLERMO RUIZ-PALACIOS
• 金额: $ 17.24万
• 依托单位: EASTERN VIRGINIA MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-01 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6588844
• 关键词: Mexico; biomedical facility; breast feeding; clinical research; clinical trials; epidemiology; field study; gastroenteritis; human milk; human subject; infant human (0-1 year); nutrition related tag; patient /disease registry

Description: The backbone of this program project is the Clinical Site Core which unites the overall aims of the proposal: 1) to isolate, characterize, and synthesize the bioactive substances in human milk (including glycoconjugates, antibodies, and anti-inflammatory factors) that protect the infant from enteropathogens; 2) to evaluate, through molecular-epidemiologic research, the protection of breast-fed infants from enteropathogens; 3) to determine, through randomized trials, the efficacy of specific bioactive substances identified in human milk to protect the infant from enteric infection and disease; and 4) to determine the effect of human milk on modulation of the immune response to enteric pathogens and vaccines. In the previous funding period of the previous application, the Clinical Site Core supported all projects. This included the sharing of demographic data and specimens, conducting field studies in Mexico (San Pedro Martir, Tlalpan) and Norfolk, specimen collection from Mexican and U.S. mothers, as well as biochemical, and biostatistical support. Field studies originating in 1987 in Mexico have enrolled in excess of 600 infants and 400 mothers. Additional studies (funded outside this project) enrolled over 600 infants in Norfolk. The Core maintained a database of all biological samples which was shared by all investigators. There have been over 2,800 milk, 1,600 blood, and 32,000 fecal samples collected, much of which has been depleted for analyses in the specific projects during 1993-8. Some of the remaining fecal samples can be used for the proposed projects, but there remain too few blood and milk samples and/or additional samples are needed to address newer aims in the current proposal.

描述：本计划项目的骨干是临床研究中心核心 其统一了该提议的总体目标：1）分离，表征， 并合成人乳中的生物活性物质（包括 糖缀合物、抗体和抗炎因子），其保护 婴儿肠道病原体; 2）通过分子流行病学评估 研究，保护母乳喂养的婴儿免受肠道病原体的侵害; 3） 通过随机试验确定特定生物活性物质的功效， 在母乳中发现的保护婴儿免受肠道感染的物质 感染和疾病;以及4）确定人乳对 调节对肠道病原体和疫苗的免疫应答。 在上一次申请的上一个资助期内，临床研究中心 核心支助所有项目。这包括分享人口数据 在墨西哥进行实地研究（圣佩德罗马蒂尔，特拉尔潘） 和诺福克，从墨西哥和美国母亲的标本收集，以及 生化和生物统计支持。实地研究始于1987年， 墨西哥已招收了600多名婴儿和400名母亲。额外 研究（由该项目以外的资金资助）在诺福克招募了600多名婴儿。 核心维持一个所有生物样本的数据库， 所有的调查员。已经有2,800多份牛奶，1,600份血液，32000份 收集的粪便样本，其中大部分已被耗尽，用于分析 1993年至1998年期间的具体项目。一些剩余的粪便样本可以 用于拟议的项目，但仍然有太少的血液和牛奶 样本和/或额外的样本，以解决新的目标， 目前的提案。