Tolerance of Healthy, Term Infants to Infant Formulas - Full Text View

Sponsored by:	Abbott Nutrition
Information provided by:	Abbott Nutrition
ClinicalTrials.gov Identifier:	NCT00543673

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 II Phase III

MedlinePlus related topics: Infant and Toddler Nutrition

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Tolerance of Healthy, Term Infants to Infant Formulas

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
Milk based formula A: Experimental Experimental milk based infant formula	Other: Milk based formula A feed as per HCP directions
Standard formula: Active Comparator standard milk based infant formula	Other: #2 Standard formula Feed as per HCP directions
Reference Human milk	Other: #3 Human Milk Feed as per HCP directions
Milk based formula C: Experimental Experimental milk based infant formula	Other: Milk based formula C Feed as per HCP direction

Eligibility

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
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
Ohio Pediatrics, Inc.
Huber Heights, Ohio, United States, 45424
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

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

Keywords provided by Abbott Nutrition:

Healthy term infants

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 15, 2009