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（Poem）研究的益生菌结果，该研究是对婴儿补充益生菌的试验（TIPS）研究的先前收集样品的二次数据分析，以防止哮喘的标志（HL080074）。旨在研究每天补充乳杆菌对婴儿的影响6个月的影响对哮喘早期标记到三岁的早期标记的影响；使用278个婴儿的双盲，安慰剂对照研究设计。在拟议的诗歌研究中，我们将采用一种新颖的16S rRNA phylachip微阵列方法，该方法是一种与培养的，众多的平行方法，用于同时对细菌的半定量检测。在从尖端队列中收集的粪便样品样本（n = 60）的样品中，使用植物芯片微阵列为表征益生菌补充剂如何改变肠道细菌群落的机会提供了机会。这首诗试验研究的总体目标是应用一项最先进的技术来开发初步数据，以确定补充每日益生菌对胃肠道细菌群落的影响。我们将（1）评估补充乳杆菌对新生儿肠道细菌群落的延长作用和（2）在补充六个月的补充期间和之后，以及（3）将细菌群落组成对哮喘早期标记发展的影响。我们假设补充乳杆菌将改变整个生命的第一年。粪便样品均已从两组（出生时1、3、6、9和12个月大）收集。我们将使用一种新颖的16S rRNA phylochip微阵列方法来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（细菌群落结构（从微阵列荧光强度中推断出的特定分类），以及细菌群落动力学（细菌群体差异）（细菌群体差异）。在此队列中，我们使用每月的随访来评估潜在的混杂因素，例如暴露于母乳喂养，抗生素，日托，兄弟姐妹，宠物和外国旅行。我们获得了基于药丸计数和粪便分析的依从性数据。我们将使用多元回归方法在乳酸杆菌定植，总细菌群落结构和细菌群落时间动态模式的范围内测试对照组和干预组之间的差异。根据该二次分析的结果，我们将进一步了解肠道细菌群落的变化如何影响特应性的发展。这些数据将使我们对补充乳杆菌的细菌群落的总体变化和变化率进行估计，以及哪些不同量度的细菌群落组成量与早期哮喘的早期标志物的变化最相关。 公共卫生相关性：我们提出了肠性微生物（Poem）研究的益生菌结果，该研究是一项试点研究，旨在帮助我们了解益生菌补充新生婴儿如何影响肠道殖民的细菌，以及细菌种群中这种变化如何影响发展哮喘的早期标志物的可能性。我们将使用一种新的尖端技术phylochip来鉴定研究中婴儿粪便样品的细菌。诗歌试验研究的数据将帮助我们找到通过补充婴儿饮食来预防哮喘早期迹象的方法。