Probiotic for Infants (NCT07054216) | Clinical Trial Compass
RecruitingNot Applicable
Probiotic for Infants
Denmark378 participantsStarted 2025-08-25
Plain-language 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.
Who can participate
Age range0 Days – 1 Day
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Born at full-term ≥37+0
✓. Birth weight ≥ 2500 g
✓. APGAR score of ≥ 7 within the first 5 min of life.
Exclusion criteria
✕. 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