Clinical Trial: Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)

Brief Summary: The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase time to occurrence of the first episode of wheezing lower respiratory tract illness (WLRI) during a third observation year after therapy