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:

AT ENROLLMENT:

* Subject must be 18-60 years of age.
* Subject must read and sign a copy of the approved Consent Form
* Female subjects must be using an effective birth control method.

INCLUSION CRITERIA AT DAY -28

* Subject must read and sign a copy of the approved Consent Form

AT CHALLENGE:

* Female subjects must be using an effective birth control method.
* Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39

Exclusion Criteria:

AT ENROLLMENT:

* Current cancer diagnosis or immunosuppressive therapy in the last 6 months
* Any clinically significant abnormalities of the upper respiratory tract
* Any clinically significant acute or chronic respiratory illness
* Any clinically significant bleeding tendency by history
* Hypertension that requires treatment with antihypertensive medications
* History of angina or other clinically significant cardiac disease
* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
* History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks
* History of drug or alcohol abuse in the 6 months preceding the study

EXCLUSION CRITERIA AT DAY -28

* Antibiotic use within 3 months prior to study start
* Female subjects with a positive urine pregnancy screen.
* History of use of probiotics in the preceding 2 weeks.

EXCLUSION CRITERIA AT CHALLENGE:

* Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
* Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two weeks prior to the study
B: Inclusion Criteria:

* age 12-24 hours of life;
* 1st degree of prematurity (functionally mature infant, gestational age 35-36 weeks);
* exclusive breast feeding during study;
* both parents must sign and date an informed consent for infant's participation in the study.

Exclusion Criteria:

* perinatal asphyxia ( Apgar score less than 8);
* significant concomitant disease (congenital birth defects, perinatal encephalopathy, TORCH - infections and other infectious disease of newborn, respiratory distress syndrome ets);
* clinically significant changes in blood analyze results (if needed);
* use of other probiotics or prebiotics during the first 28 days of study participation.
C: Inclusion Criteria:

* Children aged 3-5 years of normal nutritional status and health

Exclusion Criteria:

* Contraindications to dairy products (lactose intolerance or cow's milk allergy)
* Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
* Chronic cough from recurring respiratory distress-related diseases
* Hirschsprung's disease
* Cystic fibrosis
* Other metabolic, neurological, or anatomic alteration that predisposes participation
* Intake of probiotics within the last 3 weeks
D: 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

Answer: D