NCT07054216

Probiotic for Infants

Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 1 Day
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
OTHER	Probiotic	Given daily from 14 days of age until 9 months of age
DIETARY_SUPPLEMENT	Placebo	Given daily from 14 days of age until 9 months of age

Timeline

• Start date: 2025-08-25
• Primary completion: 2027-12-31
• Completion: 2028-07-01
• First posted: 2025-07-08
• Last updated: 2025-08-28

Locations

2 sites across 1 country: Denmark