Growth and Tolerance of Infants Fed Milk-Based Infant Formula

Abbott

Status: Completed

Conditions: Gastro-Intestinal Tolerance

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03967132

AL29A

Details and patient eligibility

About

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

Enrollment: 189 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good health as determined from participant's medical history
• Singleton from a full-term birth with a gestational age of 37-42 weeks
• Birth weight was > 2490 g (~5 lbs. 8 oz.)
• If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
• If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other 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 (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study by AN.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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189 participants in 3 patient groups

Control Infant Formula

Active Comparator group

Description:

Milk-based infant formula

Treatment:

Other: Control Infant Formula

Experimental Infant Formula

Experimental group

Description:

Milk-based Infant Formula with oligosaccharides

Treatment:

Other: Experimental Infant Formula

Reference Group

Other group

Description:

Human-milk fed

Treatment:

Other: Reference Group