Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
Brief Summary: Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin.

The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.


Options:
A: Inclusion Criteria:

* Singleton, 10-14 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Anemia at time of birth
* Current use of iron or iron-containing supplements
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance
B: Inclusion Criteria:

* Full-term newborn (≥37 weeks of gestation)
* Birth weight ≥2500 g and ≤4000 g
* Apgar score \> 8
* Infants from birth to 40 days of age at the time of enrollment
* Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn.

Exclusion Criteria:

* Infants with congenital heart defect, congenital illness or malformations, severe gastrointestinal disease, kidney, liver, central nervous system, or metabolic disease, or born from mothers with gestational diabetes.
C: Inclusion Criteria:

* healthy newborn infant
* birth weight between 2500g and 4800g
* singleton birth
* mother's BMI before pregnancy was between 26 and 25
* for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
* for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
* having obtained signed informed consent of legal representative

Exclusion Criteria:

* body weight smaller than 5th percentile for that gestational age
* newborn whose mother has diabetes
* newborn whose mother has a drug dependence during pregnancy
* newborn currently participating in another trial
D: Inclusion Criteria:

* Singleton birth
* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
* Birth weight of 2500 g (5 lbs 8 oz) or more
* Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent obtained for infant's participation in the study
* Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through 18 months of age

Infants receiving formula:

* 3 to 60 days of age at randomization, inclusive (day of birth is considered day 0)
* Exclusively receiving infant formula for at least 72 hours prior to randomization
* Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Infants receiving human milk:

* 150-180 days of age at registration, inclusive (day of birth is considered day 0)
* Mother has intention to predominately provide mother's own breast milk through at least 10 months of age

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* First degree relative with known autism, intellectual disability, schizophrenia, or bipolar disorder or an inherited disorder of myelination
* Major pre- and/or perinatal issues (such as maternal pre-eclampsia, placental abruption, maternal alcohol or illicit drug use during pregnancy)
* Major delivery complications (such as neonatal hypoxia or neonatal illness requiring a greater than 2-day NICU stay)
* Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
* 5 minute APGAR \< 7
* Infant was born large for gestational age (LGA) (as confirmed by the hospital birth records) from mother who was diabetic at childbirth
* Infant has been identified with inadequate weight gain or failure to thrive by a health care professional (HCP)
* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
* Parent(s) or legal guardian unable to speak English at a level to provide informed consent

Infants receiving formula:

• Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization

Infants receiving human milk:

• Use of infant formula and/or donor milk more than three times per week prior to registration

Answer: B