Tolerance of Healthy Term Infants Fed Infant Formulas
- Conditions
- Infant, Newborn
- Interventions
- Other: milk protein formulas, varying carbohydrate/protein sources
- Registration Number
- NCT00705562
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age
- medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 milk protein formulas, varying carbohydrate/protein sources Experimental milk protein based infant formula with varying carbohydrate and protein source 2 milk protein formulas, varying carbohydrate/protein sources Experimental milk protein based infant formula with varying carbohydrate and protein source 3 milk protein formulas, varying carbohydrate/protein sources Experimental milk protein based infant formula with varying carbohydrate and protein source 4 milk protein formulas, varying carbohydrate/protein sources Experimental milk protein based infant formula with varying carbohydrate and protein source 5 milk protein formulas, varying carbohydrate/protein sources Experimental milk protein based infant formula with varying carbohydrate and protein source
- Primary Outcome Measures
Name Time Method Gastrointestinal tolerance 0-8 days of age until 28 days of age
- Secondary Outcome Measures
Name Time Method GI and intake parameters 0-8 to 28 days of age
Trial Locations
- Locations (15)
Global Clinical Investigation
🇺🇸Aventura, Florida, United States
PediaResearch, Inc
🇺🇸Owensboro, Kentucky, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
University of Iowa
🇺🇸Coralville, Iowa, United States
Kentucky Pediatric Research
🇺🇸Bardstown, Kentucky, United States
Medical Associates Clinic
🇺🇸Dubuque, Iowa, United States
Midwest Children's Health Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Ohio Pediatric Research Association
🇺🇸Huber Heights, Ohio, United States
Institute of Clinical Research
🇺🇸Mayfield Heights, Ohio, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Primary Physicians Research, Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Pediatric Associates of Fairfield
🇺🇸Fairfield, Ohio, United States
University of South Florida
🇺🇸Tampa, Florida, United States
The Center for Human Nutrition
🇺🇸Omaha, Nebraska, United States