Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy & Cost-Effectiveness of Lactobacillus Reuteri DSM 17938 Administration to Prevent the Risk of Respiratory or Gastrointestinal Infections in Child Day Care Centers: A Randomized, Double Blind, Placebo Control Trial (RDDCT).
Brief Summary: Randomized, doble blind, clinical, controlled trial aimed to investigate the role of Lactobacillus reuteri DSM 17938 in the prevention of gastrointestinal and respiratory tract infections in mexican children who attend day care centers.

Primary Outcome: The primary outcome will be "days with diarrhoea". Secondary Outcomes: a) Days with respiratory tract infections (RTI); b) Days of absences from day care centre; c) Days of antibiotic use; d) Days of medical office visits or emergency visits; and e) Direct and Indirect costs.

Methods: Prospective, randomized, double blind, placebo controlled trial to realize in 260 healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be recruit from Child Care Centers in Mexico and randomly allocated to receive either 1 x 108 colony-forming units of Lactobacillus reuteri DSM 17938 or placebo, each day for 12 weeks, follow up for other additionally 12 weeks of observation. Days with respiratory tract infections (RTI); days of absences from day care centre; days of antibiotic use; days of medical office visits or emergency visits; and direct and Indirect costs will be compare between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness analysis


Options:
A: Inclusion Criteria:

* Children aged 12-36 months at enrollment
* Resident of Sangam Vihar and likely to be in the area for 1 year.
* Parents consenting to participate in the trial.

Exclusion Criteria:

* Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
* Children currently as part of a different Iron/Zinc supplementation program.
* Children known to be allergic to milk.
* Children who are severely malnourished and requiring hospitalization.
B: Inclusion Criteria:

* Healthy infants
* Born at term (≥36 weeks of gestation)
* Any gender
* 6 to 36 months old
* Same socioeconomic background
* Written informed consent from parents or legal guardians

Exclusion Criteria:

* Birth weight \<2500 g
* Congenital anomalies
* Chronic diseases
* Failure to thrive
* Allergy or atopic disease
* Recent (within the preceding 4 weeks) exposure to probiotics, prebiotics, or antibiotics.
* Concurrent participation in other clinical trials
C: 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.
D: 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

Answer: B