Tolerance of Healthy Term Infants Fed Infant Formulas #3

Completed · Phase 3

Conditions studied: Gastrointestinal Tolerance

In brief

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Key facts

Study ID

NCT00977964

Run by

Abbott Nutrition

People needed

270

Starts

2009-09-01

Expected to finish

2010-01-01

Last updated by the study team

2010-11-25

Who can join

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

You may qualify if…

• Infant is judged to be in good health.
• Infant is a singleton from a full term birth.
• Infant's birth weight was > 2490 g (\~5 lbs 8 oz.
• Infant is between 0 and 8 days of age at enrollment.
• Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

You may not qualify if…

• An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Infant has been treated with antibiotics.
• Infant has received probiotics.

Where it is running

• Alabama Clinical Therapeutics — Dothan, Alabama, United States
• All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc — Plantation, Florida, United States
• SCORE Physician Alliance, LLC — St. Petersburg, Florida, United States
• University of South Florida — Tampa, Florida, United States
• North Georgia Clinical Research — Dalton, Georgia, United States
• Northpoint Pediatrics, LLC — Indianapolis, Indiana, United States
• Medical Associates Clinic, PC — Dubuque, Iowa, United States
• Kentucky Pediatric / Adult Research — Bardstown, Kentucky, United States
• Pediatric Associates of Mount Carmel, Inc — Cincinnati, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Dayton Clinical Research — Dayton, Ohio, United States
• Ohio Pediatric Research Association, Inc. — Huber Heights, Ohio, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States
• The Jackson Clinic, PA — Jackson, Tennessee, United States
• Rockwood Clinic North - Pediatrics — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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