Tolerance of Healthy Term Infants Fed Infant Formulas #3
- Conditions
- Gastrointestinal Tolerance
- Registration Number
- NCT00977964
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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.
- 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 The primary variable is Gastrointestinal tolerance. 1-28 days of age
- Secondary Outcome Measures
Name Time Method The secondary variables are additional measures of GI tolerance and parental feedback. 1-28 days of age
Trial Locations
- Locations (15)
Alabama Clinical Therapeutics
🇺🇸Dothan, Alabama, 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
🇺🇸Tampa, Florida, United States
North Georgia Clinical Research
🇺🇸Dalton, Georgia, United States
Northpoint Pediatrics, LLC
🇺🇸Indianapolis, Indiana, United States
Medical Associates Clinic, PC
🇺🇸Dubuque, Iowa, United States
Kentucky Pediatric / Adult Research
🇺🇸Bardstown, Kentucky, United States
Pediatric Associates of Mount Carmel, Inc
🇺🇸Cincinnati, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Scroll for more (5 remaining)Alabama Clinical Therapeutics🇺🇸Dothan, Alabama, United States