Tolerance of Healthy, Term Infants to Infant Formulas

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy

Treatments: Other: Milk based formula A; Other: #3 Human Milk; Other: #2 Standard formula; Other: Milk based formula C

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543673

AK53

Details and patient eligibility

About

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Enrollment: 180 patients

Sex: All

Ages: Under 8 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• judged to be in good health.
• singleton from a full term birth with a gestational age of 37-42 weeks
• birth weight was > 2490 g (~5 lbs 8 oz)
• between 0 and 8 days of age at enrollment.
• Infant's parent(s) or a LAR has voluntarily signed and dated an 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 thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
• Infant has been treated with antibiotics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups

Milk based formula A

Experimental group

Description:

Experimental milk based infant formula

Treatment:

Other: Milk based formula A

Standard formula

Active Comparator group

Description:

standard milk based infant formula

Treatment:

Other: #2 Standard formula

Reference

Other group

Description:

Human milk

Treatment:

Other: #3 Human Milk

Milk based formula C

Experimental group

Description:

Experimental milk based infant formula

Treatment:

Other: Milk based formula C