Expired Study
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Asheboro, North Carolina 27203


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


NCT ID:

NCT02401217


Primary Contact:

Study Chair
Marlene Borschel, PhD, RD
Abbott Nutrition


Backup Contact:

N/A


Location Contact:

Asheboro, North Carolina 27203
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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