Status:
COMPLETED
Tolerance of Healthy Term Infants Fed Infant Formulas #3
Lead Sponsor:
Abbott Nutrition
Conditions:
Gastrointestinal Tolerance
Eligibility:
All Genders
Up to 8 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
Eligibility Criteria
Inclusion
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth.
- Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.
- Infant is between 0 and 8 days of age at enrollment.
- Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
Exclusion
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics.
- Infant has received probiotics.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00977964
Start Date
September 1 2009
End Date
January 1 2010
Last Update
November 25 2010
Active Locations (15)
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1
Alabama Clinical Therapeutics
Dothan, Alabama, United States, 36305
2
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, United States, 33324
3
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States, 33710
4
University of South Florida
Tampa, Florida, United States, 33606