Tolerance of Healthy, Term Infants to Infant Formulas
- Conditions
- Healthy
- Registration Number
- NCT00543673
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- judged to be in good health.
- singleton from a full term birth with a gestational age of 37-42 weeks
- birth weight was > 2490 g (~5 lbs 8 oz)
- between 0 and 8 days of age at enrollment.
- Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
- An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
- Infant has been treated with antibiotics.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean rank stool consistency (MRSC) Study Day 1 to Visit 3
- Secondary Outcome Measures
Name Time Method MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting 4 months
Trial Locations
- Locations (10)
The Pediatric Clinic
🇺🇸North Little Rock, Arkansas, United States
USF
🇺🇸Tampa, Florida, United States
North Georgia Clinical Research, White's Pediatrics
🇺🇸Dalton, Georgia, United States
Medical Associates Clinic
🇺🇸Dubuque, Iowa, United States
Midwest Children's Health Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
The Childrens Medical Group LLC
🇺🇸Poughkeepsie, New York, United States
Levine Childrens Hospital
🇺🇸Charlotte, North Carolina, United States
Ohio Pediatrics, Inc.
🇺🇸Huber Heights, Ohio, United States
Institute of Clinical Research
🇺🇸Mayfield Heights, Ohio, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
The Pediatric Clinic🇺🇸North Little Rock, Arkansas, United States