Investigation of A Children's Beverage Containing Different Probiotics

This study has been completed.
Sponsor:
Collaborator:
Boys Town National Research Hospital
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00990002
First received: October 5, 2009
Last updated: May 9, 2011
Last verified: May 2011
  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

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Bryan Liu, Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT00990002     History of Changes
Other Study ID Numbers: 6002
Study First Received: October 5, 2009
Last Updated: May 9, 2011
Health Authority: United States: Food and Drug Administration
United States: Boys Town National Research Hospital Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014