Tolerance of Healthy Term Infants Fed Infant Formulas

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00705562
First received: June 24, 2008
Last updated: January 2, 2009
Last verified: January 2009
  Purpose

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.


Condition Intervention Phase
Infant, Newborn
Other: milk protein formulas, varying carbohydrate/protein sources
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance of Healthy Term Infants Fed Infant Formulas

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Gastrointestinal tolerance [ Time Frame: 0-8 days of age until 28 days of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GI and intake parameters [ Time Frame: 0-8 to 28 days of age ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 2
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 3
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 4
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 5
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age

Exclusion Criteria:

  • medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705562

Locations
United States, Florida
Global Clinical Investigation
Aventura, Florida, United States, 33180
University of South Florida
Tampa, Florida, United States, 33606
United States, Iowa
University of Iowa
Coralville, Iowa, United States, 52241
Medical Associates Clinic
Dubuque, Iowa, United States, 52002
United States, Kentucky
Kentucky Pediatric Research
Bardstown, Kentucky, United States, 40004
PediaResearch, Inc
Owensboro, Kentucky, United States, 42301
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Nebraska
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States, 68504
The Center for Human Nutrition
Omaha, Nebraska, United States, 68105
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Pediatric Associates of Fairfield
Fairfield, Ohio, United States, 45014
Ohio Pediatric Research Association
Huber Heights, Ohio, United States, 45424
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
United States, Pennsylvania
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States, 15241
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Director: Steven Davis, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00705562     History of Changes
Other Study ID Numbers: AK62
Study First Received: June 24, 2008
Last Updated: January 2, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014