Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

Completed · Phase 2/Phase 3

Conditions studied: Infant, Newborn

In brief

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

Key facts

Study ID

NCT00798382

Run by

Abbott Nutrition

People needed

154

Starts

2008-12-01

Expected to finish

2009-09-01

Last updated by the study team

2012-06-14

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 with a gestational age of 37-42 weeks.
• Infant's birth weight was > 2490 g (\~5 lb 8 oz).
• Infant is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
• Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

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

• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, 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 Health Pediatrics — Tampa, Florida, United States
• North Georgia Clinical Research — Dalton, Georgia, United States
• Medical Associates Clinic — Dubuque, Iowa, United States
• Kentucky Pediatric Research — Bardstown, Kentucky, United States
• PediaResearch, LLC — Owensboro, Kentucky, United States
• Midwest Children's Health Research Institute, LLC — Lincoln, Nebraska, United States
• Center for Human Nutrition — Omaha, Nebraska, 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 — Huber Heights, Ohio, United States
• Institute of Clinical Research, LLC — Mayfield Heights, Ohio, United States
• Primary Physician's Research, Inc — Pittsburgh, Pennsylvania, United States
• West Virginia University, Department of Pediatrics — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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