Clinical Trial

Probiotic for Infants

Study acronym: BABIES II
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-07; most recent amendment 2025-08-27.
Status change: Not Yet Recruiting → Recruiting 2025-08-27
Trial Details
NCT Number NCT07054216
Lead Sponsor Hvidovre University Hospital
Collaborators: University of Copenhagen, Chr Hansen
Conditions Healthy Infants
Enrollment 378 participants
Start Date 2025-08-25
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-28