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
Sponsors and collaborators
Hvidovre University Hospital
Lead sponsor
Chr Hansen
Collaborator