Characterization of the Gastrointestinal Microbiota in Newborn Infants
Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
Hvidovre University Hospital
40 participants
Mar 4, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria11
- Healthy pregnant person in gestational week 36+0-38+0
- Age ≥ 18 years
- Normal singleton pregnancy
- Ability to read and speak Danish
- Normal ultrasound scan of the fetus at gestational age 19-20 weeks
- Plan to exclusively breastfeed
- Provided voluntary written informed consent.
- Inclusions Criteria for the newborn:
- Born at full-term ≥37+0
- Birth weight above 2500 g
- APGAR score of at least 7 within the first 5 min of life.
Exclusion Criteria10
- Pregnancy at over 38+0 weeks' gestation at recruitment
- Multiple pregnancy
- Pregnancy with any fetal abnormality
- Alcohol or drug abuse
- Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
- 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
- No other probiotics than the study product.
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Interventions
Given daily from enrollement to 28 days of life
Given daily from enrollement to 28 days of life
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06789484