Probiotic Outcomes in Enteric Microflora (POEM) Study

肠道菌群 (POEM) 研究中的益生菌结果

• 批准号: 7738964
• 负责人: Michael D Cabana
• 金额: $ 37.45万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7738964
• 关键词: Adherence; Affect; Age; Age-Months; Antibiotics; Asthma; Atopic Dermatitis; Bacteria; Base Composition; Birth; Blood; Breast Feeding; CD4 Positive T Lymphocytes; Clinical; Collaborations; Communities; Community Developments; Complex; Cutaneous; Data; Data Analyses; Detection; Development; Dietary Supplementation; Disease; Double-Blind Method; Eczema; Enrollment; Enteral; Eosinophilia; Exposure to; Feces; Fluorescence; Goals; IgE; Immunologic Markers; Infant; Intestines; Investigation; Lactobacillus; Lactobacillus casei; Life; Measures; Methods; Neonatal; Newborn Infant; Outcome; Pattern; Peripheral Blood Mononuclear Cell; Pilot Projects; Population; Predictive Value; Probiotics; Randomized; Recording of previous events; Recurrence; Research Design; Research Personnel; Rhinitis; Ribosomal RNA; Risk; Sampling; Science; Serum; Siblings; Structure; Supplementation; Taxon; Technology; Testing; Travel; Wheezing; antigen challenge; atopy; base; cohort; design; double-blind placebo controlled trial; follow-up; gastrointestinal; group intervention; infancy; microbial; novel; pet animal; pill; placebo controlled study; prevent; public health relevance; response

DESCRIPTION (provided by applicant): We propose the Probiotic Outcomes on Enteric Microbiotia (POEM) Study, which is a secondary data analysis of previously collected samples from the Trial of Infant Probiotic Supplementation (TIPS) Study to Prevent Markers of Asthma (HL080074). TIPS was designed to examine the effects of daily Lactobacillus casei supplementation in infants for 6 months on the development of early markers of asthma to age three; using a double-blind, placebo controlled study design with 278 infants. In the proposed POEM Study, we will apply a new and novel 16S rRNA PhyloChip microarray approach that is a culture-independent, massively parallel method for simultaneous semi-quantitative detection of bacteria. Use of a PhyloChip microarray on a sample of previously collected stool samples from the TIPS cohort (n=60) presents an opportunity for characterizing how probiotic supplementation altered the intestinal bacterial community. The overall goal of the POEM pilot study is apply a state-of-the-science technology to develop preliminary data to determine the impact of daily probiotic supplementation on the gastrointestinal bacterial community. We will (1) assess the immediate effect and (2) prolonged effect of Lactobacillus supplementation on neonatal intestinal bacterial community during and after a six-month period of supplementation and (3) correlate the effects of the bacterial community composition on the development of early markers of asthma. We hypothesize that Lactobacillus supplementation will change the pattern of intestinal colonization throughout the first year of life. Stool samples have been collected from both groups (at birth, 1, 3, 6, 9 and 12 months of age). We will assess neonatal gut bacterial community composition using a novel 16S rRNA PhyloChip microarray approach, which will assess Lactobacillus colonization, bacterial community structure (presence or absence of specific taxa as inferred from microarray fluorescence intensity), as well as bacterial community dynamics (longitudinal differences in bacterial community development). In this cohort, we have used monthly follow-up to assess potential confounding factors such as exposure to breastfeeding, antibiotics, daycare, siblings, pets and foreign travel. We have data on adherence based on pill counts and stool analyses. We will use multivariate regression methods to test for differences between the control and intervention groups in the extent of Lactobacillus colonization, total bacteria community structure and bacterial community temporal dynamic patterns. Based on the results of this secondary analysis, we will further understand how changes in gut bacterial community may affect the development of atopy. This data will give us an estimate of the overall magnitude and rate of changes in bacterial communities with Lactobacillus supplementation, as well as which of different measures of bacterial community composition are most associated with changes in early markers of asthma. PUBLIC HEALTH RELEVANCE: We propose the Probiotic Outcomes on Enteric Microbiotia (POEM) Study, which is a pilot study to help us understand how probiotic supplementation of newborn babies affects the bacteria that colonize their gut, and how such changes in the bacterial population affect the likelihood of developing early markers of asthma. We will use a new cutting-edge technology, the PhyloChip, to identify bacteria from stool samples of the infants in the study. Data from the POEM pilot study will help us find ways of potentially preventing early signs of asthma through dietary supplementation of infants.

描述（由申请人提供）：我们提出了肠道微生物群益生菌结果（POEM）研究，这是对先前从婴儿益生菌补充（TIPS）研究中收集的样品进行的二次数据分析，以预防哮喘标志物（HL080074）。TIPS旨在检查6个月婴儿每日补充干酪乳杆菌对3岁前哮喘早期标志物发展的影响；采用双盲，安慰剂对照研究设计278名婴儿。在拟议的POEM研究中，我们将应用一种新的16S rRNA PhyloChip微阵列方法，该方法是一种不依赖于培养的大规模并行方法，用于同时进行半定量检测细菌。对先前从TIPS队列（n=60）收集的粪便样本使用PhyloChip微阵列提供了表征益生菌补充如何改变肠道细菌群落的机会。POEM试点研究的总体目标是应用最先进的科学技术来开发初步数据，以确定每日补充益生菌对胃肠道细菌群落的影响。我们将(1)评估补充乳酸菌对新生儿肠道细菌群落的即时影响和(2)在补充乳酸菌6个月期间和之后的长期影响，(3)将细菌群落组成对哮喘早期标志物发展的影响联系起来。我们假设补充乳酸杆菌将改变整个生命第一年肠道定植的模式。收集了两组婴儿（出生、1、3、6、9和12个月大时）的粪便样本。我们将使用一种新型16S rRNA PhyloChip微阵列方法评估新生儿肠道细菌群落组成，该方法将评估乳酸杆菌定植、细菌群落结构（通过微阵列荧光强度推断是否存在特定分类群）以及细菌群落动态（细菌群落发育的纵向差异）。在这个队列中，我们使用每月随访来评估潜在的混杂因素，如母乳喂养、抗生素、日托、兄弟姐妹、宠物和国外旅行。我们有基于药片数量和粪便分析的依从性数据。我们将使用多元回归方法来检验对照组和干预组在乳酸菌定植程度、总细菌群落结构和细菌群落时间动态模式方面的差异。基于这一二次分析的结果，我们将进一步了解肠道细菌群落的变化如何影响特应性反应的发展。这一数据将使我们对补充乳酸杆菌后细菌群落变化的总体幅度和速率进行估计，以及哪种不同的细菌群落组成测量方法与哮喘早期标志物的变化最相关。