Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Stopped early · Phase 3

Conditions studied: Healthy Term Infants

In brief

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

Key facts

Study ID

NCT01137877

Run by

Abbott Nutrition

People needed

399

Starts

2010-05-01

Expected to finish

2010-10-01

Last updated by the study team

2010-11-25

Who can join

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

You may qualify if…

• in good health
• singleton full term birth
• Birth weight > 2490 g.
• Infant is between 0 and 11 days of age
• Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
• If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
• If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
• not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

You may not qualify if…

• adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.

Where it is running

• Arkansas Children's Hospital Research — Little Rock, Arkansas, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Norwich Pediatric Group — Norwich, Connecticut, United States
• All Women's Healthcare of West Broward, Inc — Plantation, Florida, United States
• SCORE Physician Alliance LLC — St. Petersburg, Florida, United States
• USF College of Medicine, USF Health, Department of Pediatrics — Tampa, Florida, United States
• Northpoint Pediatrics — Indianapolis, Indiana, United States
• University of Louisville Department of Pediatrics — Louisville, Kentucky, United States
• New England Center for Clinical Research, Inc — Fall River, Massachusetts, United States
• Wayzata Children's Clinic Ridgeview Research — Chaska, Minnesota, United States
• Midwest Children's Health Research Institute, LLC — Lincoln, Nebraska, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Cary Pediatric Center — Cary, North Carolina, United States
• Dayton Clinical Research — Dayton, Ohio, United States
• Ohio Pediatric Research Association, Inc — Huber Heights, Ohio, United States
• Parma Pediatrics — Parma, Ohio, United States
• Comprehensive Pediatrics, Inc — Westlake, Ohio, United States
• Sanford Clinic Family Medicine 34th and Kiwanis — Sioux Falls, South Dakota, United States
• DCOL Center for Clinical Research — Longview, Texas, United States
• Rockwood Clinic North Pediatrics — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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