Please select the eligibility criteria that correspond to the clinical trial below.
Title: Nutritional Management of Infants With Chronic Diarrhea
Brief Summary: The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.


Options:
A: 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
B: Inclusion Criteria:

* Less than or equal to 12 months of age at enrollment
* Candidates for elemental feeding
* Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion Criteria:

* Any non-approved concomitant study
C: Inclusion Criteria:

* Singleton, 1-7 days of age at registration or randomization
* Term infant with appropriate birth weight for gestational age
* Either solely formula fed or exclusively receiving mother's own breast milk
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Caesarean delivery
* Infant was born from a mother with Type 1 diabetes
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or history of formula or human milk intolerance
* Signs of acute infection of current use of antibiotics
D: Inclusion Criteria:

* Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):

  * Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
  * Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum \[sIgE\>0,35 KUI/L\] or skin prick test \[SPT ≥ 3 mm\]) OR
  * Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
* Aged ≤12 years of age at screening.
* Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
* Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion Criteria:

* Children who receive breastfeeding at study enrolment.
* Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine \[excluding eye drops\] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
* Severe anaphylactic reaction \[required ≥ 2 doses of epinephrine\] to milk or breast milk within the past 2 years;
* Existing illness that could interfere with formula acceptance or identification of allergic reactions.
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Answer: B