Characterization of the Gastrointestinal Microbiota in Newborn Infants

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Healthy Infants

In brief

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).

Key facts

Study ID

NCT06789484

Run by

Hvidovre University Hospital

People needed

40

Starts

2025-03-04

Expected to finish

2025-12-31

Last updated by the study team

2025-04-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria for the pregnant person:
• 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.

You may not qualify if…

• Exclusion Criteria for the pregnant person:
• 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.
• Exclusion Criteria for the newborn :
• 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.

Where it is running

• Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling — Hvidovre, Denmark (enrolling)

Full record on ClinicalTrials.gov

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