Actively Recruiting
Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Led by Universitair Ziekenhuis Brussel · Updated on 2026-02-19
768
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
U
Universitair Ziekenhuis Brussel
Lead Sponsor
B
BioGaia AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born at UZ Brussel with gestational age of 37 weeks or more
- Infant is healthy at pre-examination
- Infant aged between 1 and 14 days at inclusion
- Legal guardian(s) able and willing to follow study instructions
- Infant suitable for participation according to study personnel
- Legal guardian(s) willing to avoid probiotic products for infant during study
- Written informed consent given by parent or legal guardian
You will not qualify if you...
- No legal guardian's command of any local language
- Infant with major congenital anomalies or suspected chronic disorders
- Infant with congenital or acquired immunodeficiency
- Infant with infection at pre-examination or in previous 7 days
- Infant admitted to neonatal intensive care unit after birth
- Infant deemed unsuitable for participation by study personnel
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
K
Koen Huysentruyt, Pediatric Gastroenterologist
CONTACT
L
Leontien Depoorter, Resident Pediatric Pulmonology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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