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

NCT07347743 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Colic
  • Healthy Infants
  • Eczema Atopic Dermatitis

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.

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Koen Huysentruyt, Pediatric Gastroenterologist · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-05-31
Completion
2028-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347743 on ClinicalTrials.gov