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RecruitingNot ApplicableNCT07054216

Probiotic for Infants

Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study

Sponsor

Hvidovre University Hospital

Enrollment

378 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

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

Min Age: 0 DaysMax Age: 1 Day

Inclusion Criteria9

  • Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
  • Singleton pregnancy
  • Ability to read and speak Danish
  • Plan to breastfeed
  • Provided voluntary written informed consent.
  • Inclusions Criteria for the newborn
  • Born at full-term ≥37+0
  • Birth weight ≥ 2500 g
  • APGAR score of ≥ 7 within the first 5 min of life.

Exclusion Criteria9

  • Pregnancy at 38 weeks + 0 or later at the time of recruitment
  • Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks
  • Alcohol or drug abuse
  • Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
  • Pregnant person with any contraindications for breastfeeding.
  • Congenital disorders that could affect their safety or the study outcome
  • Admission to Neonatal Intensive Care Unit for more than 24 hours
  • Participation in another clinical intervention study which can interfere with this probiotic intervention
  • Probiotics other than the study product.

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Interventions

OTHERProbiotic

Given daily from 14 days of age until 9 months of age

DIETARY_SUPPLEMENTPlacebo

Given daily from 14 days of age until 9 months of age

Locations(2)

Hvidovre Hospital

Hvidovre, Region Sjælland, Denmark

Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling

Hvidovre, Denmark

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NCT07054216