Clinical Trial

Characterization of the Gastrointestinal Microbiota in Newborn Infants

Study acronym: BABIES I
Recruiting
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Record status
This record was last updated April 13, 2025 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-17.
Status change: Not Yet Recruiting → Recruiting 2025-04-10
Trial Details
NCT Number NCT06789484
Lead Sponsor Hvidovre University Hospital
Collaborators: Chr Hansen
Conditions Healthy Infants
Enrollment 40 participants
Start Date 2025-03-04
Primary Completion 2025-10-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-13