Tolerance of Healthy Infants Fed Infant Formulas

Abbott

Status: Completed

Conditions: Gastrointestinal Tolerance

Treatments: Other: Phase 1- Arm 1 Infant Formula; Other: Phase 2- Arm 2 Infant Formula; Other: Phase 2- Arm 3 Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02401217

AL12

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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.

Trial design

126 participants in 3 patient groups

Phase 1-Arm 1 Infant Formula

Experimental group

Description:

Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum.

Treatment:

Other: Phase 1- Arm 1 Infant Formula

Phase 2- Arm 2 Infant Formula

Active Comparator group

Description:

Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum.

Treatment:

Other: Phase 2- Arm 2 Infant Formula

Phase 2- Arm 3 Infant Formula

Experimental group

Description:

Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum.

Treatment:

Other: Phase 2- Arm 3 Infant Formula