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Investigation of A Children's Beverage Containing Different Probiotics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990002
First Posted: October 6, 2009
Last Update Posted: May 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boys Town National Research Hospital
Information provided by:
Mead Johnson Nutrition
  Purpose
Investigating different bioactive ingredients in children's beverages and the effect on blood serum markers.

Condition
Immunity

Study Type: Observational
Study Design: 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.

Further study details as provided by Mead Johnson Nutrition:

Estimated Enrollment: 30
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
Boys Town National Research Hospital
  More Information

Responsible Party: Bryan Liu, Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT00990002     History of Changes
Other Study ID Numbers: 6002
First Submitted: October 5, 2009
First Posted: October 6, 2009
Last Update Posted: May 10, 2011
Last Verified: May 2011