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

RecruitingNAAges 1 Day - 14 DaysAllUniversitair Ziekenhuis Brussel
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks. 2. Infant is healthy at the time of pre-examination. 3. Infant is aged between 1 and 14 days old at the time of inclusion. 4. Legal guardian(s) are able and willing to follow the study instructions 5. Infant is suitable for participation in the study according to the investigator/ study personnel 6. Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3). 7. Informed written consent given by parent / legal guardian Exclusion Criteria: 1. No legal guardian's command of any local language 2. 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) 3. Infant is suffering from congenital or acquired immunodeficiency 4. Infant is suffering from an infection at the time of pre-examination or previous 7 days 5. Infant is admitted post-partum to the neonatal intensive care unit 6. Infant is not suitable for participation in the study according to the study personnel´s opinion
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What it tests

  • Two probiotic Limosilactobacillus reuteri strains
  • Placebo
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Where

1 site
Universitair Ziekenhuis Brussel
Jette, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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