Yogurt beverages as a vehicle to deliver high dose probiotics

描述（由申请人提供）：益生菌是活的微生物，当给予足够的量时，可以改善健康。通常，益生菌以粉末、药丸或液体的形式被摄入，专门用于药用。酸奶可以是益生菌的有效载体，但在美国，通常酸奶的配方中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快递代理，因为它在父母和孩子中很受欢迎，可能会提高依从性。我们建议评估酸奶配方与益生菌菌株的剂量，导致恢复在粪便。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作为一种载体，为儿童提供促进健康的益生菌。本研究的具体目标是确定含有至少1010菌落形成单位(CFU)/份的乳酸双歧杆菌（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：确定在1-3岁服用青霉素类抗生素的儿童中，与服用安慰剂饮料相比，饮用含有高剂量益生菌的酸奶饮料是否能降低抗生素相关腹泻的发生率。目标2：评估儿童在生病时每天定期饮用酸奶的可行性。目的3：确定补充的Bb-12益生菌是否能在胃肠道中存活，并能从饮用Bb-12酸奶饮料的参与者的粪便中恢复。这一提议是对PA的直接回应，我们的目标与NCCAM的使命是一致的。NCCAM已经确定了需要进一步调查的研究领域，并指出：“在研究中使用充分定义的产品和最佳剂量表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、药理学、生物利用度和最佳给药剂量；2)识别替代标记；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，以增强检测所研究治疗的有意义的积极效果的能力。一种现成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对儿童及其父母更有吸引力，更适合长期食用。

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.