Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Brief Summary: This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a 1-month follow-up.


Options:
A: Inclusion Criteria:

* children aged 12-48 months attending educational program (either at nursery or primary school)

Exclusion Criteria:

* concomitant chronic/congenital diseases and disabilities,
* active tuberculosis,
* congenital cardiac defects,
* autoimmune diseases,
* immunodeficiency,
* chronic inflammatory bowel diseases,
* celiac diseases,
* cystic fibrosis,
* metabolic diseases,
* malignancy,
* chronic pulmonary diseases,
* malformation of the GI tract,
* history of allergy,
* severe wasting (less than 3 Standard deviations of weight-for-height z score),
* diarrhea on admission,
* antibiotic,
* pre/pro/symbiotic or immunostimulants use within 2 weeks before study start.
B: Inclusion Criteria:

* Subject whose parents/legal guardians had given written informed consent,
* Male or female, aged 3 to 6 years (upper bound excluded),
* Attending day-care centres or preschools 5 days a week in the Moscow area,
* Subject found medically healthy (in particular, free of respiratory and GI tract symptoms),
* Subject who appreciated dairy products and multi-fruit flavour.

Exclusion Criteria:

* Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol.
* Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), or with any known food or respiratory allergy.
* Subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes...) or any past or actual health condition that could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive...).
* Subject having experienced any infectious disease during the last 7 days.
* Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had been using laxatives during the week prior his participation to the study.
* Subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study.
* Subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation...) or with eating disorders (anorexia, bulimia...).
* Subject currently receiving, or who had received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics, antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid antiinflammatory substances, immunosuppressant treatment...
* Subject already enrolled in another clinical study, or currently under an exemption period from a previous study.
* Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
C: Inclusion Criteria:

* Healthy children attending day care at kindergartens located in the Zagreb's city centre
* Age from 1 year to 7 years
* Attendance at daycare centers: \> 3 days per week
* Signed informed consent by the parents

Exclusion Criteria:

* Immunodeficiency
* Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)
* Neoplasms
* Severe chronic disorders
D: 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

Answer: B