Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
Universitair Ziekenhuis Brussel
768 participants
Jan 31, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07347743