Tolerance of Healthy Term Infants Fed Infant Formulas #4

Completed · Phase 3

Conditions studied: Healthy Term Infants

In brief

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

Key facts

Study ID

NCT01155414

Run by

Abbott Nutrition

People needed

168

Starts

2010-03-01

Expected to finish

2010-07-01

Last updated by the study team

2011-11-01

Who can join

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

You may qualify if…

• Singleton full term birth in good health
• Birth weight was > 2490 g.
• Between 0 and 8 days of age.
• Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to 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, unless instructed otherwise by their healthcare professional.
• 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.

You may not qualify if…

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics, LLC — Dothan, Alabama, United States
• SCORE Physician Alliance — St. Petersburg, Florida, United States
• University of Iowa — Coralville, Iowa, United States
• Medical Associates Clinic, PC — Dubuque, Iowa, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Ohio Pediatric Research Association — Huber Heights, Ohio, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States
• Pediatric Clinical Research Office — Hershey, Pennsylvania, United States
• The Jackson Clinic, PA — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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