Yogurt beverages as a vehicle to deliver high dose probiotics

描述(申请人提供)：益生菌是活的微生物，当给予足够的量时，可能会改善健康。通常，益生菌被作为补充剂以粉末、药丸或液体的形式摄入，专门为药用而设计。酸奶可以是一种有效的益生菌载体，但通常在美国可以买到的酸奶的配方没有注意到最佳的益生菌菌株或剂量。酸奶也是一种有吸引力的递送媒介，因为它在父母和孩子中很受欢迎，可能会提高合规性。我们建议评估使用益生菌菌株配制的酸奶的剂量，以导致粪便中的恢复。该项目的长期目标是证明含有益生菌的酸奶饮料可以成功地用作向儿童提供有益健康的益生菌的载体。这项研究的具体目标是确定每份含有至少1010个菌落形成单位(CFU)的乳酸双歧杆菌(BB-12)的酸奶饮料是否可以预防抗生素相关性腹泻(AAD)。我们有三个具体目标来实现这些目标。目的#1：确定与服用青霉素类抗生素的1-3岁儿童相比，饮用含有高剂量益生菌的酸奶饮料是否降低了抗生素相关性腹泻的发生率。目的#2：评估儿童在生病时每天定期饮用可饮用酸奶的可行性。目的#3：确定补充的BB-12益生菌是否在胃肠道存活，并可从饮用BB-12酸奶饮料的参与者的粪便中回收。这项提议是对PA的直接回应，我们的目标与NCCAM的使命一致。NCCAM已经确定了需要进一步调查的研究领域，指出：“在研究中使用充分定义的产品和最佳剂量计划可以降低失败的风险，这可能会阻碍对其他有希望的模式的进一步研究。”因此，NCCAM建议进行以下研究：1)确定有效成分、药理、生物利用度和最佳剂量；2)确定替代标记物；以及3)评估研究的可行性。这些研究的结果将成为设计更大规模试验的基础，这些试验具有增强的能力，以检测正在研究的疗法的有意义的积极效果。容易获得的含有高剂量益生菌的酸奶有可能对世界各地儿童的健康产生积极影响，因为酸奶可能比药物类益生菌制剂更吸引儿童和他们的父母长期食用。 公共卫生相关性：益生菌是活的微生物，当给予足够的量时，可能会改善健康。通常，益生菌是以粉末、药丸或液体的形式作为补充剂摄入的，专门为药用而设计。益生菌可作为发酵乳制品的成分。含有益生菌的酸奶饮料可能被成功地用作向儿童提供有益健康的益生菌的载体，从而产生一种功能性食品；这是一种在营养价值之外提供健康益处的食品。我们的主要目的是观察大剂量益生菌饮料是否可以预防服用青霉素类抗生素的1-3岁儿童的抗生素相关性腹泻。此外，这项研究将使我们能够评估这种在食品中传递益生菌的方法的可行性，如果成功，未来将增强健康的其他方面。

DESCRIPTION (provided by applicant): 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. Public Health Relevance: Probiotics are live microorganisms that, when administered in sufficient amounts, may improve health. Generally probiotics are ingested as supplements in powder, pill or liquid forms, designed specifically for medicinal benefit. Probiotics may be included as ingredients in fermented dairy products. A probiotic-containing yogurt beverage can potentially be used successfully as a vehicle for delivering health-enhancing probiotics to children, resulting in a functional food; that is a food providing health benefits beyond its nutritional value. Our primary aim is to see if a high dose probiotic drink can prevent antibiotic-associated diarrhea in children ages 1-3 taking a penicillin-class antibiotic. Additionally, this study will allow us to assess the feasibility of this approach to delivering probiotics in a food product and, if successful, in the future enhance other aspects of health.