Yogurt beverages as a vehicle to deliver high dose probiotics

酸奶饮料作为提供高剂量益生菌的载体

• 批准号: 8491751
• 负责人: DANIEL J MERENSTEIN
• 金额: $ 31.7万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8491751
• 关键词: Adverse effects; Age; Anorexia; Antibiotics; Area; Asthma; Attention; Bacteria; Beverages; Bifidobacterium; Biological Availability; Breast Feeding; Child; Child health care; Clinical Trials; Colony-forming units; Consumption; Counseling; Dairy Products; Data; Diarrhea; Disease; Dose; Drug Formulations; Etiology; Failure; Feasibility Studies; Feces; Food; Gastrointestinal tract structure; Goals; Health; Health Benefit; Hypersensitivity; Image; Incidence; Infant; Intervention; Intestines; Investigation; Life; Liquid substance; Mission; Modality; National Center for Complementary and Alternative Medicine; Necrotizing Enterocolitis; Nutrient; Nutritional; Oral; Outcome; Outcome Study; Parents; Participant; Patients; Penicillins; Pharmacologic Substance; Pharmacology; Placebo Control; Placebos; Play; Population; Powder dose form; Preparation; Prevention; Primary Care Physician; Probiotics; Public Health; Recovery; Regimen; Rehydrations; Reporting; Research; Research Design; Risk; Role; Schedule; Source; Strategic Planning; Surrogate Markers; United States; Yogurt; abstracting; base; capsule; design; dosage; drinking; effectiveness clinical trial; functional food; improved; microorganism; nutrition; pill; prevent; response; transmission process

Abstract: Probiotics are live microorganisms that, when administered in sufficient amounts, may improve health. Often, probiotics are ingested as supplements in powder, pill or liquid forms, designed specifically for medicinal benefit. Yogurt can be an effective delivery vehicle for probiotics, but generally yogurts available in the United States are not formulated with attention to optimal probiotic strains or dose. Yogurt is also an attractive delivery agent because of its popularity with parents and children, likely improving compliance. We propose to evaluate yogurt formulated with a probiotic strain at a dose that results in recovery in stools. The long-term goal of this project is to demonstrate that a probiotic-containing yogurt beverage can be used successfully as a vehicle for delivering health-enhancing probiotics to children. The specific goals of this study are to determine if a yogurt drink containing Bifidobacterium lactis (Bb-12) at a minimum 1010 colony forming units (CFU)/per serving can prevent antibiotic-associated diarrhea (AAD). We have three specific aims to accomplish these goals. Aim #1: To determine if consumption of a yogurt drink containing a high dose of probiotics decreases the incidence of antibiotic-associated diarrhea in children ages 1-3 taking a penicillin-class antibiotic compared to a matching placebo drink. Aim #2: To evaluate the feasibility of children consuming a drinkable yogurt on a regular daily basis when the children are ill. Aim #3: To determine if the supplemental Bb-12 probiotics survive the gastrointestinal tract and can be recovered from the stools of participants consuming the Bb-12 yogurt drink. This proposal is in direct response to a PA and our Aims are in consort with NCCAM's mission. NCCAM has identified areas of research needing further investigation, stating, "Use of adequately defined products and optimal dosage schedules in studies decreases the risk of failures that might discourage further research into otherwise promising modalities." Therefore, NCCAM recommends studies designed to: 1) determine active ingredients, pharmacology, bioavailability and optimal dosing; 2) identify surrogate markers; and, 3) assess study feasibility. The outcomes of these studies will form the basis for designing larger trials with an enhanced ability to detect a meaningful positive effect of the therapy under study. A readily available yogurt with high dose probiotics has the potential to positively impact the health of children around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like probiotic preparations.

抽象的： 益生菌是活的微生物，如果以足够的量给药，可以改善健康。 通常，益生菌被摄入为粉末，药丸或液体形式的补充剂，专为专为 药物益处。酸奶可以是益生菌的有效递送工具，但通常可用的酸奶 在美国，不关注最佳益生菌菌株或剂量。酸奶也是 有吸引力的送货代理，因为它在父母和孩子上的知名度可能会提高依从性。我们 提议评估剂量时用益生菌菌株配制的酸奶，从而导致粪便恢复。这 该项目的长期目标是证明可以使用含益生菌的酸奶饮料 成功地作为向儿童提供健康增强益生菌的工具。这个具体目标 研究是确定至少1010个菌落的酸奶饮料是否含有乳酸菌（BB-12） 形成单位（CFU）/每份份量可以预防抗生素相关的腹泻（AAD）。我们有三个特定的 旨在实现这些目标。目的＃1：确定消费酸奶饮料是否含有高 益生菌的剂量降低了1-3岁儿童抗生素相关腹泻的发生率 与匹配的安慰剂饮料相比，青霉素级抗生素。目标＃2：评估可行性 儿童生病时，每天定期食用可喝酸奶的孩子。目标＃3：到 确定补充BB-12益生菌是否在胃肠道中存活，可以从 参与者食用BB-12酸奶饮料的凳子。该建议是对PA的直接回应， 我们的目标是与NCCAM的使命相处。 NCCAM已经确定了需要进一步的研究领域 调查，指出：“在研究中使用适当定义的产品和最佳剂量时间表 降低了失败的风险，这可能会阻止对原本有希望的方式进行进一步研究。” 因此，NCCAM建议设计为：1）确定活性成分，药理学， 生物利用度和最佳剂量； 2）确定替代标记； 3）评估研究可行性。这 这些研究的结果将构成设计具有提高能力的较大试验的基础 该疗法正在研究的有意义的积极作用。容易获得的酸奶，具有高剂量益生菌 有可能积极影响世界各地儿童的健康，因为酸奶可能会更多 比药物样益生菌吸引儿童及其父母长期消费 准备。