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Tolerance of Healthy, Term Infants to Infant Formulas

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00543673
First received: October 5, 2007
Last updated: July 3, 2008
Last verified: June 2008
History of Changes
  Purpose

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula


Condition Intervention Phase
Healthy
 Other: Milk based formula A
Other: #2 Standard formula
Other: #3 Human Milk
Other: Milk based formula C
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Mean rank stool consistency (MRSC) [ Time Frame: Study Day 1 to Visit 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milk based formula A
Experimental milk based infant formula
 Other: Milk based formula A
feed as per HCP directions
Other Name: AN0710A
Active Comparator: Standard formula
standard milk based infant formula
 Other: #2 Standard formula
Feed as per HCP directions
Other Name: AN0710B
Reference
Human milk
 Other: #3 Human Milk
Feed as per HCP directions
Other Name: Human Milk
Experimental: Milk based formula C
Experimental milk based infant formula
 Other: Milk based formula C
Feed as per HCP direction
Other Name: AN0710C

  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543673

Locations
United States, Arkansas
The Pediatric Clinic
North Little Rock, Arkansas, United States, 72117
United States, Florida
USF
Tampa, Florida, United States, 33606
United States, Georgia
North Georgia Clinical Research, White's Pediatrics
Dalton, Georgia, United States, 30721
United States, Iowa
Medical Associates Clinic
Dubuque, Iowa, United States, 52001
United States, Nebraska
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States, 68505
United States, New York
The Childrens Medical Group LLC
Poughkeepsie, New York, United States, 12603
United States, North Carolina
Levine Childrens Hospital
Charlotte, North Carolina, United States, 28207
United States, Ohio
Ohio Pediatrics, Inc.
Huber Heights, Ohio, United States, 45424
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
United States, Texas
Scott & White Memorial Hospital
Temple, Texas, United States, 78508
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Timberly A. Williams, M.S. Abbott Nutrition, Abbott Laboratories
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00543673     History of Changes
Other Study ID Numbers: AK53
Study First Received: October 5, 2007
Last Updated: July 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Nutrition:
Healthy term infants

ClinicalTrials.gov processed this record on May 16, 2013