Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Brief Summary: The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.


Options:
A: Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to ≤12 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
* Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
* Having obtained his/her legal representative's informed consent

Exclusion:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Any major gastrointestinal disease or abnormalities other than CMA
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
* Immunodeficiency
* Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
* Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
* Unstable asthma
* Severe uncontrolled eczema
* Severe anaphylactic reaction to milk within the last 2 years
* Severe anaphylactic reaction to breastmilk within the last 2 years
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial.
B: Inclusion Criteria:

1. Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:

   * Positive double-blind placebo controlled food challenge with cow milk
   * A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
   * Confirmed history of a reaction to cow milk protein with CM-specific IgE of \>15kU/L for children over two years and \> 5kU/L for children under two years.
   * Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
   * No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
   * For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
2. Written informed consent / ability to give informed consent.
3. These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,

Exclusion Criteria:

All subjects

1. Infants \<5lb 8oz at birth
2. Infants \< 37 weeks gestation
3. Infants with severe concurrent illness or major congenital malformations
4. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
5. Unable to adhere to protocol instructions due to non compliance of parent or caregiver
6. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
7. Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
8. An infant of any personnel connected with the study
9. Infants whose parent/caregiver is younger than the legal age of consent
10. For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
11. These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.
C: Inclusion Criteria:

* mechanically ventilated neonates of all gestational ages and birth weights
* less than 1 month of postnatal age admitted to the NICU
* SNAP (Score of Neonatal Acute Physiology) \> 10
* projected requirement for continued parenteral nutrition of at least 1 week duration

Exclusion Criteria:

* renal or hepatic failure
* requiring insulin administration
* requiring extracorporeal life support
* known inherited metabolic disorders
* known uniformly fatal congenital anomalies
D: Inclusion Criteria:

1. Age: 6 months-36 months
2. Sex: only males, for precise separation of stool and urine
3. History of diarrhoea duration of \<48 hours
4. Dehydration: some

Exclusion Criteria:

1. Diarrhoea due to Vibrio cholerae that requires antimicrobial therapy by dark field microscopy
2. Dysentery (blood in stool), which requires antimicrobial therapy
3. Concomitant infection(s) e.g. ARI, meningitis, and sepsis
4. History of taking antibiotics for the current diarrhoea episode
5. Severely malnourished children (Wt for length \< 70%) or patients with edema

Answer: A