Investigation of A Children's Beverage Containing Different Probiotics
INVESTIGATION OF CHANGES IN LEUKOCYTE POPULATIONS AMONG CHILDREN RECEIVING A FOLLOW-ON COW'S MILK-BASED FORMULA CONTAINING DIFFERENT BIOACTIVE INGREDIENTS.
1 other identifier
observational
30
1 country
1
Brief Summary
Investigating different bioactive ingredients in children's beverages and the effect on blood serum markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 10, 2011
May 1, 2011
1.7 years
October 5, 2009
May 9, 2011
Conditions
Study Arms (3)
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 Criteria
children 2-4 years of age
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mead Johnson Nutritionlead
- Father Flanagan's Boys' Homecollaborator
Study Sites (1)
Boys Town National Research Hospital
Boys Town, Nebraska, 68010, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 6, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 10, 2011
Record last verified: 2011-05