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Recruiting Not applicable

Probiotic for Infants

NCT07054216 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-08-25
Last updated
2025-08-28

Condition(s) studied

Healthy Infants

Investigational drug(s) / intervention(s)

ProbioticPlacebo

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

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

Study 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

Sex
ALL
Min age
0 Days
Max age
1 Day
Healthy volunteers
Accepted
"Inclusion Criteria" Inclusion Criteria for the pregnant person 1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0) 2. Singleton pregnancy 3. Ability to read and speak Danish 4. Plan to breastfeed 5. Provided voluntary written informed consent. Inclusions Criteria for the newborn 1. Born at full-term ≥37+0 2. Birth weight ≥ 2500 g 3. APGAR score of ≥ 7 within the first 5 min of life. "Exclusion Criteria" Exclusion Criteria for the pregnant person 1. Pregnancy at 38 weeks + 0 or later at the time of recruitment 2. Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks 3. Alcohol or drug abuse 4. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre 5. Pregnant person with any contraindications for breastfeeding. Exclusion Criteria for the newborn 1. Congenital disorders that could affect their safety or the study outcome 2. Admission to Neonatal Intensive Care Unit for more than 24 hours 3. Participation in another clinical intervention study which can interfere with this probiotic intervention 4. Probiotics other than the study product.

Primary outcome measure(s)

  • Total abundance of Bifidobacteria — At 3 months of age
    Abundance of Bifidobacteria in infant fecal samples by quantitative PCR

Trial sites (2)

FacilityCityRegionStatus
Hvidovre Hospital Hvidovre Region Sjælland Recruiting
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling Hvidovre Denmark Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07054216 on ClinicalTrials.gov ↗ ← All trials in Denmark