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Investigation of A Children's Beverage Containing Different Probiotics

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ClinicalTrials.gov Identifier: NCT00990002
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : May 10, 2011
Sponsor:
Collaborator:
Father Flanagan’s Boys’ Home
Information provided by:
Mead Johnson Nutrition

Brief Summary:
Investigating different bioactive ingredients in children's beverages and the effect on blood serum markers.

Condition or disease
Immunity

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INVESTIGATION OF CHANGES IN LEUKOCYTE POPULATIONS AMONG CHILDREN RECEIVING A FOLLOW-ON COW'S MILK-BASED FORMULA CONTAINING DIFFERENT BIOACTIVE INGREDIENTS.
Study Start Date : September 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Group/Cohort
Control
A children's milk-based beverage
experimental probiotic 1
children's milk-based beverage containing a bioactive ingredient
experimental probiotic 2
children's milk-based beverage containing a different bioactive ingredient




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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
children 2-4 years of age
Criteria

Inclusion Criteria:

  • Children 2-4 years of age, weight and length for age within the 10th to 90th percentiles as plotted on the NCHS growth chart
  • Consuming cow's milk for at least one month

Exclusion Criteria:

  • Serious concurrent illness or acute infection
  • Using systemic antibiotics or steroids
  • Recent probiotic use
  • Feeding difficulties or intolerance to cow's milk
  • Conditions effecting normal growth and development
  • Immunodeficiencies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990002


Locations
United States, Nebraska
Boys Town National Research Hospital
Boys Town, Nebraska, United States, 68010
Sponsors and Collaborators
Mead Johnson Nutrition
Father Flanagan’s Boys’ Home

Responsible Party: Bryan Liu, Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT00990002     History of Changes
Other Study ID Numbers: 6002
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011