RecruitingNot ApplicableNCT07347743

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.


Sponsor

Universitair Ziekenhuis Brussel

Enrollment

768 participants

Start Date

Jan 31, 2026

Study Type

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

Min Age: 1 DayMax Age: 14 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and Two probiotic Limosilactobacillus reuteri strains for people with colic, eczema atopic dermatitis, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Day to 14 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTTwo 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_SUPPLEMENTPlacebo

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

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NCT07347743


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