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RECRUITING
NCT07054216
NA

Probiotic for Infants

Sponsor: Hvidovre University Hospital

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.

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

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

Locations (2)

Hvidovre Hospital

Hvidovre, Region Sjælland, Denmark

Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling

Hvidovre, Denmark