Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.

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.

NCT Number	NCT07347743
Lead Sponsor	Universitair Ziekenhuis Brussel Collaborators: BioGaia AB
Conditions	Colic, Healthy Infants, Eczema Atopic Dermatitis
Enrollment	768 participants
Start Date	2026-01-31
Primary Completion	2028-05 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-19