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Clinical Trials in Denmark / NCT06789484
Recruiting Not applicable

Characterization of the Gastrointestinal Microbiota in Newborn Infants

NCT06789484 · tracked via the Priya Life Science Denmark tracker
Sponsor
Hvidovre University Hospital
Phase
Not applicable
Started
2025-03-04
Last updated
2025-04-13

Condition(s) studied

Healthy Infants

Investigational drug(s) / intervention(s)

ProbioticPlacebo

Probiotic: Given daily from enrollement to 28 days of life

Placebo: Given daily from enrollement to 28 days of life

Study 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

Sex
ALL
Min age
—
Max age
1 Day
Healthy volunteers
Accepted
Inclusion Criteria: * Inclusion Criteria for the pregnant person: 1. Healthy pregnant person in gestational week 36+0-38+0 2. Age ≥ 18 years 3. Normal singleton pregnancy 4. Ability to read and speak Danish 5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks 6. Plan to exclusively breastfeed 7. Provided voluntary written informed consent. * Inclusions Criteria for the newborn: 1. Born at full-term ≥37+0 2. Birth weight above 2500 g 3. APGAR score of at least 7 within the first 5 min of life. Exclusion Criteria: * Exclusion Criteria for the pregnant person: 1. Pregnancy at over 38+0 weeks' gestation at recruitment 2. Multiple pregnancy 3. Pregnancy with any fetal abnormality 4. Alcohol or drug abuse 5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre 6. 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. No other probiotics than the study product.

Primary outcome measure(s)

  • Recovery of the probiotic strain in newborn/infant fecal samples — Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
    Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR.

Trial sites (1)

FacilityCityRegionStatus
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling Hvidovre Denmark Recruiting

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Other trials for the same condition

Probiotic for Infants Recruiting
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants 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 NCT06789484 on ClinicalTrials.gov ↗ ← All trials in Denmark