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Characterization of the Gastrointestinal Microbiota in Newborn Infants

Study acronym: BABIES I
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2025 to Mar 4, 2025
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06789484
Lead Sponsor Hvidovre University Hospital
Collaborators: Chr Hansen
Conditions
(from sponsor)		 Healthy Infants
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov