Decreasing Rates of Illness in Kids (DRINK)
|ClinicalTrials.gov Identifier: NCT00356382|
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : May 14, 2008
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Lactobacillus (L.) casei||Phase 3|
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 $1.8 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 daycare/school 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||638 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Decreasing Rates of Illnesses in Kids (DRINK)|
|Study Start Date :||September 2006|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
- Mean of sick days due to upper-respiratory and gastro-intestinal infections and diarrhea.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356382
|United States, District of Columbia|
|Georgetown University Department of Family Medicine|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Daniel Merenstein, MD||Georgetown University|