Study to Investigate the Potential of Probiotics in Yogurt
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the consumption of a yogurt drink containing a
      high dose of probiotics decreases absences, due to illnesses, in daycare centers for children
      between the ages of 1 and 3.
    

Detailed description: 
      It is reported that more than half of all young children attend daycare centers in the United
      States. Absences due to illnesses are costly both on an individual and societal level; these
      absences are generally due to diarrhea or upper respiratory infections.

      In the U.S., children under five years of age experience 20-35 million episodes of diarrhea
      per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all
      visits by children), more than 200,000 hospitalizations (13% of hospital admissions in
      children under five years), and 325-425 deaths annually. In 1991, the outpatient costs of
      treating diarrhea in children under age three was calculated at 0.6-1 billion dollars per
      year.

      Respiratory illness is among the leading causes of death in children under five years of age.
      Approximately 200,000 deaths in the U.S. and 3.9 million deaths worldwide are attributed to
      respiratory illnesses. Respiratory illness is also the most frequent reason for physician
      consultation, with more than 40% of all pediatric outpatient visits related to respiratory
      illness. According to a recent study, 39% of children attending daycare experienced acute
      otitis media (ear infection) and 26% reported allergies. Most notably, 10% of children
      attending daycare were admitted to the hospital due to respiratory illnesses.

      We have chosen BB-12 as the probiotic for this study as it is one of the best characterized
      probiotics with a long safety record in children, a well-proven ability to colonize the human
      intestinal tract, and demonstrated efficacy for different pediatric conditions. Furthermore,
      BB-12 is a commercially available probiotic strain that has been used in a number of feeding
      and clinical trials.

      In fact, there is a new infant formula on the market, using the identical strain we are, in
      the first commercially available probiotic infant formula available in the United States. Not
      only has BB-12 been found to survive transit through the stomach, small intestine and colon,
      but also long-term consumption of BB-12 formula at levels as high as 1 billion CFU/g (240 g
      serving) have been found to be safe.

      Our overall goal is to demonstrate that a probiotic-containing yogurt beverage can be used
      successfully as a vehicle for delivering health-enhancing probiotics; more specifically to
      determine if a yogurt drink containing Bifidobacterium lactis BB-12 at a minimum 1010 colony
      forming units (CFU)/per serving can prevent daycare absences.

      The rationale for focusing on food as a vehicle for the transmission of probiotics is that it
      has the potential to benefit children more than using probiotics in a more medicinal manner,
      such as pills or capsules. By providing an intervention in the form of a yogurt drink,
      parents are given a more convenient and simple alternative to traditional probiotic
      supplements. As yogurt is known to be a nutrient dense food, a yogurt drink is likely to be
      more appealing to both children and their parents for long-term consumption than
      pharmaceutical-like preparations. Although compliance with most medicinal regimens is around
      50%, by offering a more attractive formulation of high dose probiotics and collaborating with
      participants we believe compliance will exceed normal levels. Ultimately, by capitalizing on
      the widely accepted healthy image of yogurt and offering a simple, convenient source of
      probiotics, we believe this product has the potential to positively impact the health of
      children around the world.
    

Intervention name(s): Bifidobacterium lactis (BB-12); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).; The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: probiotic; health; bifidobacterium lactis; BB-12