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RECRUITING
NCT07347743
NA

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

Sponsor: Universitair Ziekenhuis Brussel

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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