TRIAL OF INFANT PROBIOTIC SUPPLEMENTATION TO PREVENT ASTHMA

婴儿益生菌补充剂预防哮喘的试验

• 批准号: 7376595
• 负责人: Michael D Cabana
• 金额: $ 0.05万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376595
• 关键词: asthma; balance; child rearing; diet; immune system; lead; parents; phenotype; placebos

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Little is known about the primary prevention of asthma. The hygiene hypothesis suggests that the absence of bacterial exposure leads to an unfavorable balance of the immune system. A controlled bacterial exposure may help create a more favorable balance in the developing immune system and lead to decreased risk of developing asthma. Lactobacillus is a bacterium found in many foods in the typical pediatric diet (e.g., yogurt), and is used as a supplement to prevent diarrhea. Due to the safety, feasibility and early promising results in preventing atopic dermatitis, Lactobacillus is an ideal bacterium to use as an exposure to test this hygiene hypothesis and see if it can create a favorable immunologic balance to help prevent asthma. Using a randomized placebo-controlled trial design, we will measure the effect of a 6-month daily exposure of Lactobacillus, as an infant formula supplement, on immune system and asthma development during the first 3 years of life. Newborn babies will be randomized to either a group that will be fed a small amount of Lactobacillus supplement each day for 6 months, or a group that will be fed a small amount of placebo each day for 6 months. We will measure the effect of the Lactobacillus on the presence and time to presentation of (1) early clinical markers for asthma development (frequent wheezing, wheezing without colds, rhinitis, and atopic dermatitis); and (2) early immunologic markers for asthma development (eosinophilia, IgE); In addition, we will (3) follow the development of markers in the immune system to assess the development of the Th phenotype by measuring the whole blood lymphocyte response to stimulants, focusing Th1 (IFN-gamma, IL-12) and Th2 cytokines (IL-10, IL-4, IL-13), as well as real-time reverse transcriptase polymerase chain reaction (RT-PCR) with PCR amplification (TaqMan) to quantify RNA transcripts. Clinical and immunologic markers will be measured up to 3 years of age. During the first six months we will also collect data on how frequently parents are actually feeding the supplement by asking parents to complete diaries, as well as pill counts at the first 3 follow-up visits. In our analysis of the data, we will use intention-to-treat analysis and will control for the impact of family, environmental, diet, and demographic factors on outcomes using multivariate regression and survival analysis techniques. We expect that when compared to controls, subjects receiving Lactobacillus will have decreased and delayed development of markers for asthma, and a greater likelihood of developing a Th1 phenotype.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。关于哮喘的主要预防知之甚少。卫生假设表明，没有细菌暴露会导致免疫系统平衡。受控的细菌暴露可能有助于在发展中的免疫系统中建立更有利的平衡，并导致患哮喘的风险降低。乳杆菌是一种在典型的小儿饮食（例如酸奶）的许多食物中发现的细菌，被用作预防腹泻的补充剂。由于安全性，可行性和早期有希望的结果，可以防止特应性皮炎，因此乳酸杆菌是一种理想的细菌，可用于检验该卫生假说，看看它是否可以创造出良好的免疫平衡以帮助预防哮喘。 使用随机的安慰剂对照试验设计，我们将衡量乳酸杆菌每天6个月暴露作为婴儿配方奶粉，对免疫系统和哮喘发育的影响。刚出生的婴儿将被随机分配给每天6个月喂养少量乳杆菌补充剂的组，或者每天将少量安慰剂喂食6个月。 我们将衡量乳酸杆菌对（1）出现（1）哮喘发育早期临床标志物（频繁喘息，无感冒，鼻炎和特应性皮炎）的早期临床标志物的影响； （2）哮喘发育的早期免疫学标记（嗜酸性粒细胞，IgE）； In addition, we will (3) follow the development of markers in the immune system to assess the development of the Th phenotype by measuring the whole blood lymphocyte response to stimulants, focusing Th1 (IFN-gamma, IL-12) and Th2 cytokines (IL-10, IL-4, IL-13), as well as real-time reverse transcriptase polymerase chain reaction (RT-PCR) with PCR amplification （Taqman）量化RNA转录本。 临床和免疫标记将测量长达3岁。在最初的六个月中，我们还将收集有关父母实际上供应补品的数据，要求父母完成日记，以及在前3个随访中的药丸计数。在我们对数据的分析中，我们将使用意向性治疗分析，并使用多元回归和生存分析技术来控制家庭，环境，饮食和人口统计学因素对结果的影响。我们预计，与对照组相比，接受乳杆菌的受试者将减少和延迟哮喘标记的发育，并且更有可能发展Th1表型。