Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
- Conditions
- Infant, Newborn
- Registration Number
- NCT00798382
- Lead Sponsor
- Abbott Nutrition
- 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 formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age. 35 days
- Secondary Outcome Measures
Name Time Method Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age 35 days
Trial Locations
- Locations (17)
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
🇺🇸Plantation, Florida, United States
SCORE Physician Alliance, LLC
🇺🇸St. Petersburg, Florida, United States
University of South Florida Health Pediatrics
🇺🇸Tampa, Florida, United States
North Georgia Clinical Research
🇺🇸Dalton, Georgia, United States
Medical Associates Clinic
🇺🇸Dubuque, Iowa, United States
Kentucky Pediatric Research
🇺🇸Bardstown, Kentucky, United States
PediaResearch, LLC
🇺🇸Owensboro, Kentucky, United States
Midwest Children's Health Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Center for Human Nutrition
🇺🇸Omaha, Nebraska, United States
Scroll for more (7 remaining)Arkansas Children's Hospital Research Institute🇺🇸Little Rock, Arkansas, United States