Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356382
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2006-07-24
Brief Title:
Decreasing Rates of Illness in Kids DRINK
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Decreasing Rates of Illnesses in Kids DRINK
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of a cultured dairy drink with high concentrations of active L casei to reduce the cumulative rate of illness in daycareschool children ages 3 to 6
Detailed Description:
Probiotics are live microorganisms which when administered in sufficient amounts may improve health Often probiotics are ingested as supplements in powder pill or liquid form designed specifically for medicinal benefit Such supplements used in children have shown some potential benefits in the treatment and prevention of various diseases including diarrhea asthma necrotizing enterocolitis and allergies
In the past few years interest has increased in the health-enhancing role f specific foods referred to as functional foods- foods providing health benefits beyond their nutritional value Yogurt a fermented milk product produced by the action of two bacteria Lactobacillus L bulgaricus and Streptococcus S thermophilus is a functional food In fact two-thirds of primary care physicians who counsel patients about nutrition recommend consuming yogurt containing live active cultures for their patients health benefit However evidence for these health outcomes is not sufficiently strong
Daycare and school centers are ideal places for the transmission of respiratory infections and childhood diarrhea often resulting in many missed days of both daycare and parental work Illnesses related to daycare centers have been estimated to cost 18 billion per year in the United States One of the primary purposes of daycare is to allow parents to work while their child is taken care of thus absences due to illnesses have many direct and indirect associated costs Unfortunately children in daycare centers have been shown to have more outpatient doctor visits emergency room visits and increased usage of prescription medicines than children in daycare
Our overall goal is to study a cultured dairy drik with an efficacious probiotic at doses that result in probiotic survival in the gastrointestinal tract and subsequently reduce illnesses in daycareschool children ages 3-6
The rationale for focusing on a drink as a vehicle for transmission of probiotics is that it has the potential for a much greater public health impact than using probiotics in a medicinal manner such as pills or capsules Yogurt and yogurt like probiotic drinks are well established and popular with children and parents a product that traditionally provides live cultures to the diet and can provide protein vitamins and minerals that are nutritious for the child Additionally these drinks are relatively inexpensive widely available and easy to ingest even for individuals with lactose intolerance These positive attributes make it an idea carrier to deliver the health benefits of probiotics
In the past few years interest has increased in the health-enhancing role f specific foods referred to as functional foods- foods providing health benefits beyond their nutritional value Yogurt a fermented milk product produced by the action of two bacteria Lactobacillus L bulgaricus and Streptococcus S thermophilus is a functional food In fact two-thirds of primary care physicians who counsel patients about nutrition recommend consuming yogurt containing live active cultures for their patients health benefit However evidence for these health outcomes is not sufficiently strong
Daycare and school centers are ideal places for the transmission of respiratory infections and childhood diarrhea often resulting in many missed days of both daycare and parental work Illnesses related to daycare centers have been estimated to cost 18 billion per year in the United States One of the primary purposes of daycare is to allow parents to work while their child is taken care of thus absences due to illnesses have many direct and indirect associated costs Unfortunately children in daycare centers have been shown to have more outpatient doctor visits emergency room visits and increased usage of prescription medicines than children in daycare
Our overall goal is to study a cultured dairy drik with an efficacious probiotic at doses that result in probiotic survival in the gastrointestinal tract and subsequently reduce illnesses in daycareschool children ages 3-6
The rationale for focusing on a drink as a vehicle for transmission of probiotics is that it has the potential for a much greater public health impact than using probiotics in a medicinal manner such as pills or capsules Yogurt and yogurt like probiotic drinks are well established and popular with children and parents a product that traditionally provides live cultures to the diet and can provide protein vitamins and minerals that are nutritious for the child Additionally these drinks are relatively inexpensive widely available and easy to ingest even for individuals with lactose intolerance These positive attributes make it an idea carrier to deliver the health benefits of probiotics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None