Growth and Safety Clinical Trial on a New Infant Formula.

Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.

The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.

A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Inclusion Criteria:

• Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days).
• Birth weight of ≥ 2,500 g and ≤ 4,500 g.
• Postnatal age ≤ 14 days.
• Singleton.
• Designated as healthy, that is no recognized diseases.
• Weight, length, weight-for-length, and head circumference within ≥ 5th and ≤ 95th percentile for age-sex according to World Health Organization (WHO) growth standards (birth to 24 months).
• Exclusive feeding and tolerating cow milk formula at time of enrollment.
• Parent(s) or legal guardians are willing and able to feed the assigned formula as sole source of nutrition.
• Parent(s) or legal guardians are willing and able to participate in anthropometric procedures.
• Parent(s) or legal guardians have voluntarily signed and dated required participation forms, such as the ICF approved by an IRB.

Exclusion Criteria:

• An infant from a multiple birth, such as twin, triplet, or the like.
• Personal or immediate family history of cow-milk protein allergy or intolerance.
• Currently on any medication to treat growth failure or that may significantly impact growth.
• Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal.
• A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy.
• Enrolled in another clinical trial involving a drug, nutrition supplement, device, or intervention.