Probiotic for Infants
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Total abundance of Bifidobacteria — At 3 months of age
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Hvidovre Hospital | Hvidovre | Region Sjælland | Recruiting |
| Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling | Hvidovre | Denmark | Not Yet Recruiting |
More Hvidovre University Hospital trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07054216 on ClinicalTrials.gov ↗ ← All trials in Denmark