Phase I: Safety and Tolerance of Lactobactocillus reuteri in Adults

第一阶段：罗伊氏乳杆菌在成人中的安全性和耐受性

• 批准号: 7663878
• 负责人: JON Marc RHOADS
• 金额: $ 22.83万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7663878
• 关键词: Abdominal colic; Adult; Affect; Bacteria; Basic Science; Carbohydrates; Child; Clinical Research; Clostridium; Colon; Communities; Complementary and alternative medicine; Complex; Crying; Data; Desire for food; Diarrhea; Exploratory/Developmental Grant; FDA approved; Feces; Future; Gases; Goals; Health; Hydrogen; Infant; Inflammatory disease of the intestine; Intestinal Diseases; Intestines; Investigation; Irritable Bowel Syndrome; Laboratories; Lactobacillus; Lactobacillus casei rhamnosus; Mission; Modification; NIH Program Announcements; National Center for Complementary and Alternative Medicine; Oral; Phase; Pilot Projects; Placebos; Probiotics; Process; Production; Public Health; Research; Research Personnel; Safety; Science; Sleep; Symptoms; Technology; Therapeutic Intervention; Time; United States National Institutes of Health; base; design; gastrointestinal; improved; in vivo; inflammatory marker

DESCRIPTION (provided by applicant): The long-term goals of this laboratory are to elucidate mechanisms of intestinal disease in infants and children and to use basic science to identify rational treatments. Relevant to the mission of NIH, this proposal is designed as a pilot study that will generate and expand the base of in vivo data and direct future research on probiotic therapeutic interventions. Additionally, the investigators aim to utilize state-of-the science technologies to determine the constituents of complex gut microbiotia that are associated with and may contribute to colic, and to examine the impact of probiotics on the composition of the bowel flora. Colic is defined as crying and fussiness for > 3 hr daily for > 3 d weekly in a child < 3 months old. Currently, there is insufficient evidence supporting any specific treatment to relieve symptoms of infants with colic, with the possible exception of hypoallergenic formula. However, there is evidence that infants with colic produce too much hydrogen gas in the intestine and that their fussiness may be improved by daily administration of certain probiotic (health-promoting) bacteria. Recently, studies in adults with irritable bowel syndrome showed significant improvement with probiotic therapy. Our hypothesis is that infants produce more hydrogen gas because of a different colonic bacterial flora and that modification of this flora with Lactobacillus rhamnosus GG will alter gas production, thereby reducing the time these infants spend crying. We choose to study Lactobacillus rhamnosus GG, one of the two probiotic strains which has received the most investigation in babies with diarrhea. L. rhamnosus GG is FDA-approved and available over-the-counter in the U.S. Relevance to public health: Colic affects at least 8% of all infants. Our studies would not only provide evidence for whether oral L. rhamnosus GG helps reduce the number of minutes each day with colic; they would also provide evidence of a possible mechanism. Specifically, we will demonstrate if L. rhamnosus GG treatment of infants with colic who have excessive breath hydrogen levels will change the bacterial community in the colon and reduce fecal markers of inflammation. In the process, we will also demonstrate if cultivation-independent analyses of stool will reveal bacterial species associated with colic that were not previously recognized.

描述（由申请人提供）：该实验室的长期目标是阐明婴儿和儿童肠道疾病的机制，并利用基础科学来确定合理的治疗方法。与NIH的使命相关，该提案被设计为试点研究，将产生和扩大体内数据的基础，并指导未来对益生菌治疗干预的研究。此外，研究人员的目标是利用科学技术来确定与绞痛相关并可能导致绞痛的复杂肠道微生物群的成分，并检查益生菌对肠道植物群组成的影响。 绞痛定义为< 3个月的儿童每天哭闹> 3小时，每周> 3天。目前，没有足够的证据支持任何具体的治疗，以减轻症状的婴儿绞痛，与可能的例外，低过敏性配方。然而，有证据表明，患有绞痛的婴儿在肠道中产生过多的氢气，并且他们的烦躁可以通过每天服用某些益生菌（促进健康）细菌来改善。最近，在成人肠易激综合征的研究显示，益生菌治疗显着改善。我们的假设是，由于不同的结肠细菌植物群，婴儿产生更多的氢气，并且用鼠李糖乳杆菌GG修饰该植物群将改变气体产生，从而减少这些婴儿哭泣的时间。我们选择研究鼠李糖乳杆菌GG，这是两种益生菌菌株之一，已收到最多的调查婴儿腹泻。L.鼠李糖GG是FDA批准的，在美国可以非处方购买。 与公共卫生的相关性：绞痛影响至少8%的婴儿。本研究不仅为L. rhamnosus GG有助于减少每天绞痛的分钟数;他们还将提供可能机制的证据。具体来说，我们将证明，如果L。rhamnosus GG治疗具有过量呼吸氢水平的绞痛婴儿将改变结肠中的细菌群落并减少炎症的粪便标记物。在这个过程中，我们还将证明，如果培养独立的粪便分析将揭示细菌物种与绞痛，以前没有认识到。