Please select the eligibility criteria that correspond to the clinical trial below.
Title: Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children Aged 1-6 Years in Low Socio-economic Urban Area of East Jakarta
Brief Summary: This is a long term study on the efficacy of dietary calcium with or without probiotic strains in reducing the mean number of episodes and duration of diarrheal disease.


Options:
A: Inclusion Criteria:

1. Aged 6 through 23 months
2. Have evidence of AOM defined as:

   * recent (within 48 hours) onset of signs and symptoms as described in the Acute Otitis Media - Severity of Symptoms (AOM-SOS) Scale AND a score of ≥3 at the time of enrollment on the AOM-SOS scale
   * middle ear effusion evidenced by the presence of at least 2 of the following:
   * decreased or absent mobility of the tympanic membrane
   * yellow or white discoloration of the tympanic membrane
   * opacification of the tympanic membrane

   AND
   * acute inflammation evidenced by one of the following:
   * 1+ bulging of the tympanic membrane with either intense erythema or otalgia
   * 2+ or 3+ bulging of the tympanic membrane
3. Has received at least 2 doses of pneumococcal conjugate vaccine
4. Parent has provided informed consent

Exclusion Criteria:

1. Toxic appearance \[capillary refill \>3 seconds, systolic blood pressure \<60 mm Hg\];
2. Inpatient hospitalization
3. Clinical or anatomical characteristics that might obscure response to treatment (tympanostomy tubes in place, cleft palate, or Down syndrome)
4. Sensorineural hearing loss (unilateral or bilateral)
5. Serious underlying systemic problems that might obscure response to infection (cystic fibrosis, neoplasm, juvenile diabetes)
6. Concomitant infection that would preclude evaluation of the response of the child's AOM to study product (pneumonia, periorbital cellulitis)
7. Acute wheezing exacerbation which may require treatment with systemic corticosteroids
8. Known renal or hepatic dysfunction or insufficiency
9. History of amoxicillin-clavulanate-associated cholestatic jaundice
10. Immune dysfunction or receipt of immunosuppressive therapy; chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease)
11. Co-medications (systemic corticosteroids, more than one dose of systemic antimicrobial therapy within 96 hours, receipt of any investigational drug or vaccine within 30 days)
12. Hypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or phenylketonuria or known hypersensitivity to aspartame
13. Unable to complete study, or no access to phone
14. Previously enrolled in this study or currently enrolled in another study
B: Inclusion Criteria:

* Child 36-48 months of age
* Child is currently attending a daycare and has attended for 6 months or less
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent

Exclusion Criteria:

* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for height \< -3 according to World Health Organization criteria
C: Inclusion Criteria:

* Apparently healthy children aged 1-6 years, with emphasize on aged 2-5 years, living permanently in low socio-economic urban areas of East Jakarta for at least 6 months
* Parents are willing to sign the informed consent and give the supplements to the children for the period of 6 months
* Capable and willing to drink liquid milk with a straw (acceptance to be tested at screening by providing a sample drink and placebo straw to be consumed under supervision for 2 days)

Exclusion Criteria:

* Calcium intake exceeding 75% of the RDA for calcium (\<375 mg/d) based on a Food Frequency Questionnaire
* Currently breastfed children
* Siblings of already included children that are living in the same household, except if it is a twin sibling
* Severely malnourished with or without oedema (Weight for height-WHZ Z-score of \<-3.00 SD)
* Symptoms of chronic/congenital diseases and disabilities, suspected Tuberculosis by clinical examination, and /or history of allergic disease.
* Taking (any) antibiotics during 2 weeks prior to start of the study (children will be included after 3 weeks of last antibiotic intake
* Participation in another clinical trial at the same time or 2 months prior to the start of this study
* Both mothers and other caregivers present in the family are illiterate
D: Inclusion Criteria:

* Pregnant women from families with at least one family member having an allergic disease

Exclusion Criteria:

* Women presenting severe immunological or other chronic diseases (rheumatoid arthritis, diabetes, inflammatory bowel disease, thyroid diseases, malignancies etc.)
* Women who cannot be expected to comply with treatment
* Women currently participating or having participated in other clinical trial during the last 2 months prior to the beginning of the intervention.

Answer: C