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 groupsSponsors and collaborators
Source ClinicalTrials.gov