NCT06789484

Characterization of the Gastrointestinal Microbiota in Newborn Infants

Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

Summary

The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain. The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).

Conditions

• Healthy Infants

Interventions

Type	Name	Description
OTHER	Probiotic	Given daily from enrollement to 28 days of life
DIETARY_SUPPLEMENT	Placebo	Given daily from enrollement to 28 days of life

Timeline

• Start date: 2025-03-04
• Primary completion: 2025-10-30
• Completion: 2025-12-31
• First posted: 2025-01-23
• Last updated: 2025-04-13

Locations

1 site across 1 country: Denmark