Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploratory Study to Evaluate the Effect of L-isoleucine Supplemented Oral Rehydration Solution in the Treatment of Acute Diarrhoea in Children and in Inducing Innate Immunity
Brief Summary: Efforts are continuing to improve the efficacy of oral rehydration solution in terms of reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery). Antimicrobial peptides, produced by the epithelial cells, represent an important component of the innate immunity of all epithelial surfaces of the body including intestine. Induction of expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and not very expensive, and its addition to oral rehydration solution might help early clearance of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help establish normal bacterial populations in the intestine, and favourably impacts the severity and duration of diarrhoea in young children. If the results are found encouraging, a therapeutic trial with adequate sample size would be justified.


Options:
A: Inclusion Criteria:

* 0 to 6 months of age inclusive
* Born at ≥ 37 weeks gestation
* Birth weight of 2500 g (5 lb 8 oz) or more
* Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
* Infants with symptoms suggestive of cow's milk allergy
* Signed Informed Consent

Exclusion Criteria:

* Infants who for whatever reasons were not discharged home as per routine
* Infants with metabolic illness requiring a special formula
* Infants fed with nasogastric tube
B: Inclusion Criteria:

* less than 18 months old
* with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (\>=6mm) or specific immunoglobulin E \>= 5 kilo-unit/L or combination
* still symptomatic while fed an extensively hydrolysed formula

Exclusion Criteria:

* Exclusively breast fed infants
* non allergic digestive enteropathy
C: 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
D: 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.

Answer: C