Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis
Brief Summary: Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.


Options:
A: 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.
B: Inclusion Criteria:

* Singleton, healthy infant
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 grams or greater
* Age between birth and 9 days of age
* Parents agree to not administer mineral or vitamin supplements during the study period
* Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria:

* Maternal, fetal or perinatal history which may have adverse effects on growth
* Multiple birth
C: Inclusion Criteria:

* Less than or equal to 6 months of age
* 36-42 weeks gestational age at birth
* Singleton or Twin birth
* Diagnosed with protein sensitive colitis
* Negative stool culture at time of study entry
* No previous history of consuming free amino acid-based medical food
* Not receiving cisapride or steroids
* No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
* No milk or soy products for the duration of the study
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: C