Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
Brief Summary: The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.


Options:
A: Inclusion Criteria (to consent):

* Infants 0-120 days of age with suspected CMA, as determined by the pediatrician or specialist, will be referred to the study. A Standard Operating Procedures (SOP) document will be provided for the clinicians to help guide their referral to the study. Physician diagnosis of CMA will be based on the following:
* Physician documented, gross or persistent microscopic blood in stool (3 positive guaiac cards on three separate stools) in the absence of other explanation (e.g., fissure, moderate-to-severe constipation) AND / OR

Infant with at least one gastrointestinal, dermatological, or respiratory allergic manifestation suggestive of CMA:

* Gastrointestinal: Chronic Diarrhea, Constipation or Vomiting/Gastro-esophageal reflux
* Dermatologic: Atopic Dermatitis or Urticaria
* Respiratory: Cough, Allergic rhinitis or Recurrent Wheezing
* General:Colic / Irritability
* No change in treatment with medications during the 7 days preceding the elimination diet and no expected change in medications during the DBPCFCs (unless otherwise medically necessary)
* Signed informed consent obtained for infants participation in the study
* Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through the length of the study period
* Willingness to comply with following inclusion criteria if found to have a positive DBPCFC screen:

  1. Caregiver(s) agree to comply with the infant elimination diet given to them by the investigator for the duration of the study
  2. Mother agrees to follow an elimination diet throughout duration of breast feeding
  3. Parent(s) or legally authorized representative agrees not to enroll infant in another interventional clinical study while participating in this study

Inclusion Criteria (to randomization):

* Positive Double Blind Placebo Controlled Food Challenge (DBPCFC).

Exclusion Criteria (to consent):

* History of anaphylaxis to milk
* Use of probiotics
* Use in the previous 4 weeks of systemic steroids
* Use of systemic immunomodulatory treatment, including biologics with an immune target such as Xolair
* Known eosinophilic GI disorders
* Episode(s) of severe repetitive vomiting and lethargy prompting an emergency room visit and occurring within 4 hours of ingesting a milk protein (i.e. consistent with FPIES)
* Co-existing autoimmune or other chronic disease or serious health problem, including celiac disease, inflammatory bowel disease, malignancy, congenital, metabolic or genetic disorders or malformations
* Intention to exclusively breast feed
* Infants born at less than 36 weeks gestation (35 weeks + 6 days is considered 35 weeks gestation)

Exclusion Criteria (to randomization):

* Severe reaction to Milk Protein during the DBPCFC
B: Inclusion

* Healthy infants
* Born vaginally (no caecerian section)
* 37+0 until 42+0
* Birth weight ± 2 SD of internationally approved growth charts
* No severe neonatal problems
* No feeding problems
* No evidence of systemic disease

Exclusion Criteria:

* Partial breast feeding at 8 weeks
* Breast feeding in the formula Group
* Formula feeding in the breast fed Group
* Caecerian section
* Treatment with antibiotics during the first 8 weeks
C: Mothers Inclusion Criteria:

* Healthy, 19-40 years of age
* Plan to exclusively breast-fed or formula-fed

Infants Exclusion Criteria:

* Gestational age \< 37 or \> 42 weeks
* Birth weight \< 2.5kg or \> 4 kg
* Having congenital diseases
* Having birth Asphyxia
* Having birth infections
D: Inclusion Criteria:

* Hospitalized preterm newborn infants, term infants and toddlers, and children and adolescents requiring parenteral nutrition (PN) for at least 5 consecutive days.
* Preterm infants were to require PN representing, at baseline, 80% of total estimated nutritional needs, and patients in the other groups (term infants toddlers; children) were to require PN representing, at baseline, at least 50% of total estimated nutritional needs.
* Patient whose parents or legally authorized representative had provided signed written informed consent

Exclusion Criteria:

* Patients with a life expectancy \< 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study were not included in the study.
* Patients with a diagnosis of shock, cardiac or renal failure with fluid overload, metabolic acidosis, respiratory failure, signs of sepsis, severe dyslipidemia, uncorrected metabolic disorders, severe sepsis, severe liver disease including cholestasis icterus, blood coagulation disorders and/or thrombophlebitis, acute myocardial infarction, or hypersensitivity to the active substance or any of the excipients of the test product, were not included in the study.
* Patients with specific nutritional requirements that could not be met by Ped3CB formulas were also excluded.

Answer: C