Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Recruiting
N/A
Interventional Study
Colic
Healthy Infants
Eczema Atopic Dermatitis
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 1 Day – 14 Days
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 768 (estimated)
- Sponsor
- Universitair Ziekenhuis Brussel · Other
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About This Trial
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 an…
Trial Locations
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Eligibility Criteria
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 ins…
Contacts
Koen Huysentruyt, Pediatric Gastroenterologist
+32 02/476.37.17
CONTACT
Leontien Depoorter, Resident Pediatric Pulmonology
+32 02/801.25.58
Leontien.Depoorter@uzbrussel.be
CONTACT