Please select the arm or intervention descriptions that belong 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: Arm Label: Bifidobacterium animalis lactis Bl-04; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Bifidobacterium lactis Bl-04, Biological: Rhinovirus | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo, Biological: Rhinovirus | Intervention Type: DIETARY_SUPPLEMENT; Name: Bifidobacterium lactis Bl-04; Assigned to Arm(s): Bifidobacterium animalis lactis Bl-04 | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: BIOLOGICAL; Name: Rhinovirus; Assigned to Arm(s): Bifidobacterium animalis lactis Bl-04, Placebo
B: Arm Label: Group I; Type: N/A; Interventions: N/A | Arm Label: Group II; Type: N/A; Interventions: N/A
C: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Arm Label: Active 1; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Lactobacillus acidophilus NCFM | Arm Label: Active 2; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus acidophilus NCFM; Assigned to Arm(s): Active 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: Combination of Lactobacillus acidophilus and Bifidobacterium lactis; Assigned to Arm(s): Active 2
D: Arm Label: Lreuteri; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lreuteri | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Lreuteri; Assigned to Arm(s): Lreuteri | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D