Status:
COMPLETED
Tolerance of Healthy Term Infants Fed Infant Formulas #4
Lead Sponsor:
Abbott Nutrition
Conditions:
Healthy Term Infants
Eligibility:
All Genders
1-8 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available pow...
Eligibility Criteria
Inclusion
- Singleton full term birth in good health
- Birth weight was \> 2490 g.
- Between 0 and 8 days of age.
- Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to 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, unless instructed otherwise by their healthcare professional.
- 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.
Exclusion
- • An adverse maternal, fetal or infant medical history and treatment with antibiotics
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01155414
Start Date
March 1 2010
End Date
July 1 2010
Last Update
November 1 2011
Active Locations (10)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Alabama Clinical Therapeutics, LLC
Dothan, Alabama, United States, 36305
3
SCORE Physician Alliance
St. Petersburg, Florida, United States, 33710
4
University of Iowa
Coralville, Iowa, United States, 52241