Accepted for Publication: September 19, 2013.
Published Online: January 13, 2014. doi:10.1001/jamapediatrics.2013.4367.
Study concept and design: Indrio, Di Mauro, Riezzo, Corvaglia, Bisceglia, Del Vecchio, Francavilla.
Acquisition of data: Civardi, Intini, Corvaglia, Ballardini, Bisceglia, Cinquetti, Brazzoduro.
Analysis and interpretation of data: Riezzo, Intini, Tafuri.
Drafting of the manuscript: Indrio, Di Mauro, Riezzo, Intini, Ballardini, Bisceglia, Brazzoduro, Del Vecchio.
Critical revision of the manuscript for important intellectual content: Civardi, Corvaglia, Bisceglia, Cinquetti, Del Vecchio, Tafuri, Francavilla.
Statistical analysis: Intini, Tafuri.
Administrative, technical, or material support: Civardi, Bisceglia.
Study supervision: Indrio, Riezzo, Bisceglia, Del Vecchio, Francavilla.
Funding/Support: This study was supported by BioGaia AB, Sweden, which provided active study product and placebo.
Role of the Sponsors: The funding source had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.