Characterization of the Gastrointestinal Microbiota in Newborn Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorHvidovre University Hospital

About this trial

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 criteria

Qualifiers

Healthy pregnant person in gestational week 36+0-38+0

Age ≥ 18 years

Normal singleton pregnancy

Ability to read and speak Danish

Disqualifiers

Pregnancy at over 38+0 weeks' gestation at recruitment

Multiple pregnancy

Pregnancy with any fetal abnormality

Alcohol or drug abuse

Trial design

Treatments tested in this trial

  • Probiotic
  • Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators