Probiotic for Infants
ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorHvidovre University Hospital
About this trial
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
Eligibility criteria
Qualifiers
Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
Singleton pregnancy
Ability to read and speak Danish
Plan to breastfeed
Disqualifiers
Pregnancy at 38 weeks + 0 or later at the time of recruitment
Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks
Alcohol or drug abuse
Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
378 Participants
are divided into 2 treatment groupsLocations
2Hvidovre Hospital2650, HvidovreRegion Sjælland, Denmark
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling2650, Hvidovre Denmark
Sponsors and collaborators
Hvidovre University Hospital
Lead sponsor
University of Copenhagen
Collaborator
Chr Hansen
Collaborator
Source ClinicalTrials.gov