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Probiotic for Infants

Study acronym: BABIES II
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Jul 15, 2025 to Aug 25, 2025
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Collaborators: 1 to 2v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT07054216
Lead Sponsor Hvidovre University Hospital
Collaborators: University of Copenhagen, Chr Hansen
Conditions
(from sponsor)		 Healthy Infants
Enrollment 378 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov