Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
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
• Infant is suitable for participation in the study according to the investigator/ study personnel
• Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
• Informed written consent given by parent / legal guardian