Study to Investigate the Potential of Probiotics in Yogurt

Phase 3

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Bifidobacterium lactis (BB-12)

Registration Number: NCT00492583

Lead Sponsor: Georgetown University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 182

Inclusion Criteria

aged 1-3
attending daycare or preschool centers at least 3 days a week
male or female
parents must speak English or Spanish
subjects or parents/legal guardians who agree to have their child refrain from consuming any other yogurts or foods containing probiotics for the duration of the study

Exclusion Criteria

subjects with developmental delays
subjects with chronic conditions such as diabetes or asthma that require daily medication
subjects with birth weight <2500 grams
subjects with strawberry allergies
subjects with active diarrhea
subjects with congenital anomalies
subjects with failure to thrive
subjects with parental belief of lactose intolerance

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink.
Bifidobacterium lactis (BB-12)	Bifidobacterium lactis (BB-12)	Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink.

Primary Outcome Measures

Name	Time	Method
Number of Days Children Are Out of School Sick	90 days	Outcome measure, "number of days children are out of school sick" was measured for the entire population

Secondary Outcome Measures