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.
Universitair Ziekenhuis Brussel
768 participants
Jan 31, 2026
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
Inclusion Criteria7
- Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- Infant is healthy at the time of pre-examination.
- Infant is aged between 1 and 14 days old at the time of inclusion.
- Legal guardian(s) are able and willing to follow the study instructions
- Infant is suitable for participation in the study according to the investigator/ study personnel
- Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
- Informed written consent given by parent / legal guardian
Exclusion Criteria6
- No legal guardian's command of any local language
- Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
- Infant is suffering from congenital or acquired immunodeficiency
- Infant is suffering from an infection at the time of pre-examination or previous 7 days
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
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Interventions
Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07347743