Actively Recruiting
Characterization of the Gastrointestinal Microbiota in Newborn Infants
Led by Hvidovre University Hospital · Updated on 2025-04-13
40
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
H
Hvidovre University Hospital
Lead Sponsor
C
Chr Hansen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Characterization of the Gastrointestinal Microbiota in Newborn Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant person between 36+0 and 38+0 weeks of gestation
- Pregnant person aged 18 years or older
- Normal singleton pregnancy
- Ability to read and speak Danish
- Normal ultrasound scan of the fetus at 19-20 weeks gestation
- Plan to exclusively breastfeed
- Provided voluntary written informed consent
- Newborn born at full term (37+0 weeks or later)
- Newborn birth weight above 2500 grams
- Newborn APGAR score of at least 7 within first 5 minutes of life
You will not qualify if you...
- Pregnancy over 38+0 weeks' gestation at recruitment
- Multiple pregnancy
- Pregnancy with any fetal abnormality
- Alcohol or drug abuse
- Plan to give birth at hospitals other than Copenhagen University Hospital Hvidovre
- Any contraindications for breastfeeding
- Newborn with congenital disorders affecting safety or study outcome
- Newborn admitted to Neonatal Intensive Care Unit for more than 24 hours
- Participation in another clinical intervention study that interferes with this probiotic study
- Use of probiotics other than the study product
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
S
Sofie Ingdam Halkjær, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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