Growth and Tolerance of Young Infants Fed Infant Formula

Abbott

Status: Completed

Conditions: Growth and Tolerance

Treatments: Other: Experimental Infant Formula; Other: Control Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT04105686

AL31A

Details and patient eligibility

About

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

Enrollment: 366 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is judged to be in good health as determined from participant's medical history.
• Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
• Participant's birth weight was > 2490 g (~5 lbs. 8 oz.).
• Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
• Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
• Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
• Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.

Exclusion criteria

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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366 participants in 3 patient groups

Control Infant Formula

Active Comparator group

Description:

Milk-based study product

Treatment:

Other: Control Infant Formula

Experimental Infant Formula

Experimental group

Description:

Milk-based study product with oligosaccharides

Treatment:

Other: Experimental Infant Formula

Reference Group

No Intervention group

Description:

Human milk-fed group