Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains … (NCT07347743) | Clinical Trial Compass
RecruitingNot Applicable
Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Belgium768 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range1 Day – 14 Days
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)
What they're measuring
1
Peak measured crying time
Timeframe: 6 weeks
2
The occurrence of infant colic at any time in the first 3 months of life.