Tolerance of Healthy Infants Fed Infant Formulas

Completed · Not applicable

Conditions studied: Gastrointestinal Tolerance

In brief

The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.

Key facts

Study ID

NCT02401217

Run by

Abbott Nutrition

People needed

126

Starts

2015-04-01

Expected to finish

2015-09-01

Last updated by the study team

2016-01-12

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Singleton from a full term birth with a gestational age of 37-42 weeks.
• Birth weight was > 2490 g (\~5 lbs 8 oz).
• Age between 0 and 30 days at enrollment.
• Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
• Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
• Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
• Voluntarily signed and dated an informed consent form (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 that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Infant treated with antibiotics.
• Participation in another study that has not been approved as a concomitant study by AN.

Where it is running

• W.O.M.B Watching Over Mothers and Babies — Tucson, Arizona, United States
• SCORE Physician Alliance LLC — St. Petersburg, Florida, United States
• White Oak Family Physicians DBA/Asheboro Research Associates — Asheboro, North Carolina, United States
• Institute of Clinical Research, LLC — Mayfield Heights, Ohio, United States
• The Cleveland Pediatric Research Center, LLC — Middleburg Heights, Ohio, United States
• Tanner Memorial Clinic — Layton, Utah, United States

Full record on ClinicalTrials.gov

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