Characterization of the Gastrointestinal Microbiota in Newborn Infants (NCT06789484) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of the Gastrointestinal Microbiota in Newborn Infants
Denmark40 participantsStarted 2025-03-04
Plain-language 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).
Who can participate
Age range1 Day
SexALL
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Inclusion criteria
✓. 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.
✓. Born at full-term ≥37+0
Exclusion criteria
✕. 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
✕
What they're measuring
1
Recovery of the probiotic strain in newborn/infant fecal samples
Timeframe: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks