This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.
Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
Infant is healthy at the time of pre-examination.
Infant is aged between 1 and 14 days old at the time of inclusion.
Legal guardian(s) are able and willing to follow the study instructions
No legal guardian's command of any local language
Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
Infant is suffering from congenital or acquired immunodeficiency
Infant is suffering from an infection at the time of pre-examination or previous 7 days
Universitair Ziekenhuis Brussel
Lead sponsor
BioGaia AB
Collaborator