Healthy Infants Clinical Trial
Official 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).
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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