Study to Investigate the Potential of Probiotics in Yogurt (SIPPY)

This study has been completed.
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00492583
First received: June 25, 2007
Last updated: July 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Bifidobacterium lactis (BB-12)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study to Investigate the Potential of Probiotics in Yogurt

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Number of Days Children Are Out of School Sick [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Outcome measure, "number of days children are out of school sick" was measured for the entire population


Enrollment: 182
Study Start Date: July 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink.
Drug: Placebo
The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
Experimental: Bifidobacterium lactis (BB-12)
Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink.
Drug: Bifidobacterium lactis (BB-12)
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).

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.

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492583

Locations
United States, District of Columbia
Georgetown University Department of Family Medicine
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
The Gerber Foundation
Investigators
Principal Investigator: Daniel J Merenstein, MD Georgetown University
  More Information

Publications:
Responsible Party: Daniel Merenstein, Georgetown University Medical Center
ClinicalTrials.gov Identifier: NCT00492583     History of Changes
Other Study ID Numbers: 2007-273
Study First Received: June 25, 2007
Results First Received: June 21, 2011
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
probiotic
health
bifidobacterium lactis
BB-12

ClinicalTrials.gov processed this record on August 18, 2014