Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Recruiting · NCT07347743 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitair Ziekenhuis Brussel
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTwo probiotic Limosilactobacillus reuteri strains
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.
Who can take part
Age range
1 Day to 14 Days
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
- 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
Where it is running
1 location listed.
- Universitair Ziekenhuis Brussel - Jette, Brussels Capital, Belgium