Status:
COMPLETED
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
Lead Sponsor:
Abbott Nutrition
Conditions:
Infant, Newborn
Eligibility:
All Genders
Up to 8 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based f...
Eligibility Criteria
Inclusion
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was \> 2490 g (\~5 lb 8 oz).
- Infant is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
- Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.
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 :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00798382
Start Date
December 1 2008
End Date
September 1 2009
Last Update
June 14 2012
Active Locations (17)
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1
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
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 Health Pediatrics
Tampa, Florida, United States, 33606