Tolerance of Healthy, Term Infants to Infant Formulas

Completed · Phase 2/Phase 3

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00543673

Run by

Abbott Nutrition

People needed

180

Starts

2007-09-01

Expected to finish

2008-06-01

Last updated by the study team

2008-07-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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