Yogurt beverages as a vehicle to deliver high dose probiotics
Yogurt beverages as a vehicle to deliver high dose probiotics
批准号:
8440639
负责人:
DANIEL J MERENSTEIN
金额:
$36.23万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-09-01 至 2014-03-31
关键词:
Adverse effectsAgeAnorexiaAntibioticsAreaAsthmaAttentionBacteriaBeveragesBifidobacteriumBiological AvailabilityBreast FeedingChildChild health careClinical TrialsColony-forming unitsConsumptionCounselingDairy ProductsDataDiarrheaDiseaseDoseDrug FormulationsEtiologyFailureFeasibility StudiesFecesFoodGastrointestinal tract structureGoalsHealthHealth BenefitHypersensitivityImageIncidenceInfantInterventionIntestinesInvestigationLifeLiquid substanceMissionModalityNational Center for Complementary and Alternative MedicineNecrotizing EnterocolitisNutrientNutritionalOralOutcomeOutcome StudyParentsParticipantPatientsPenicillinsPharmacologic SubstancePharmacologyPlacebo ControlPlacebosPlayPopulationPowder dose formPreparationPreventionPrimary Care PhysicianProbioticsPublic HealthRecoveryRegimenRehydrationsReportingResearchResearch DesignRiskRoleScheduleSourceStrategic PlanningSurrogate MarkersUnited StatesYogurtabstractingbasecapsuledesigndosagedrinkingeffectiveness clinical trialfunctional foodimprovedmicroorganismnutritionpillpreventresponsetransmission process
中文摘要
摘要:
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,益生菌是作为补充剂以粉末、丸剂或液体形式摄入的,
药用效益。酸奶可以是益生菌的有效载体,但通常酸奶
在美国,没有注意到最佳益生菌菌株或剂量。酸奶也是
有吸引力的交付代理,因为它的流行与父母和儿童,可能提高遵守。我们
建议评估用益生菌菌株配制的酸奶,其剂量导致粪便中的恢复。的
这个项目的长期目标是证明含有益生菌的酸奶饮料可以用于
成功地作为向儿童提供健康增强益生菌的载体。具体目标是
研究是确定含有至少1010个菌落的乳双歧杆菌(Bb-12)的酸奶饮料
形成单位(CFU)/每份可以预防腹泻相关性腹泻(AAD)。我们有三个具体的
旨在实现这些目标。目的#1:确定是否消费含有高浓度的酸奶饮料
益生菌剂量降低了1-3岁儿童腹泻的发病率,
青霉素类抗生素与相应的安慰剂饮料相比。目标#2:评估
当孩子生病时,孩子每天定期饮用酸奶。目标3:
确定补充的Bb-12益生菌是否能在胃肠道中存活,
食用Bb-12酸奶饮料的参与者的粪便。这项建议是对巴勒斯坦权力机构的直接回应,
我们的目标与NCCAM的使命一致。NCCAM已经确定了需要进一步研究的领域
研究中使用充分定义的产品和最佳给药方案,
降低了失败的风险,失败可能会阻碍对其他有前途的模式的进一步研究。"
因此,NCCAM建议进行以下研究:1)确定活性成分,药理学,
生物利用度和最佳剂量; 2)鉴定替代标记物;和3)评估研究可行性。的
这些研究的结果将为设计更大规模的试验奠定基础,
有意义的积极影响的治疗研究。一个容易获得的酸奶与高剂量的益生菌
有可能对全世界儿童的健康产生积极影响,因为酸奶可能会比其他食品更受欢迎。
比药物类益生菌更能吸引儿童及其父母长期食用
准备工作
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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A Phase II randomized controlled trial to evaluate the role of BB-12 in antibiotic-associated diarrhea and its effects on the gut microbiome
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依托单位:
Yogurt beverages as a vehicle to deliver high dose probiotics
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Yogurt beverages as a vehicle to deliver high dose probiotics
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THE DRINK STUDY-DECREASING RATES OF ILLNESSES IN KIDS
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