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Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Sponsor: Universitair Ziekenhuis Brussel
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.
Official title: Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
Key Details
Gender
All
Age Range
1 Day - 14 Days
Study Type
INTERVENTIONAL
Enrollment
768
Start Date
2026-01-31
Completion Date
2028-12
Last Updated
2026-02-19
Healthy Volunteers
Yes
Interventions
Two probiotic Limosilactobacillus reuteri strains
Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
Placebo
Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.
Locations (1)
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium