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Probiotic for Infants
Sponsor: Hvidovre University Hospital
Summary
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
Official title: Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study
Key Details
Gender
All
Age Range
0 Days - 1 Day
Study Type
INTERVENTIONAL
Enrollment
378
Start Date
2025-08-25
Completion Date
2028-07-01
Last Updated
2025-08-28
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic
Given daily from 14 days of age until 9 months of age
Placebo
Given daily from 14 days of age until 9 months of age
Locations (2)
Hvidovre Hospital
Hvidovre, Region Sjælland, Denmark
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark