Decreasing Rates of Illness in Kids (DRINK)
Condition: Healthy
Study type: Interventional
Phase: Phase 3

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
      daycare/school 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 $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.
    

Intervention name(s): Lactobacillus (L.) casei
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: probiotic; Lactobacillus (L.) casei; cultured dairy drink; Health