Actively Recruiting
Probiotic for Infants
Led by Hvidovre University Hospital · Updated on 2025-08-28
378
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
Sponsors
H
Hvidovre University Hospital
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotic for Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant person above 18 years of age in gestational week 36+0 to 38+0 at Visit 0
- Singleton pregnancy
- Ability to read and speak Danish
- Plan to breastfeed
- Provided voluntary written informed consent
- Newborn born at full term (37+0 weeks or more)
- Newborn birth weight at least 2500 g
- Newborn APGAR score of 7 or higher within the first 5 minutes of life
You will not qualify if you...
- Pregnancy at 38 weeks + 0 or later at the time of recruitment
- Pregnancy with significant fetal abnormality found at ultrasound at 19-20 weeks gestation
- Alcohol or drug abuse
- Plan to give birth at hospitals other than Copenhagen University Hospital Hvidovre
- Pregnant person with any contraindications to breastfeeding
- Newborn with congenital disorders affecting safety or study outcomes
- Newborn admitted to Neonatal Intensive Care Unit for more than 24 hours
- Participation in another clinical intervention study that could interfere
- Use of probiotics other than the study product
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hvidovre Hospital
Hvidovre, Region Sjælland, Denmark, 2650
Actively Recruiting
2
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark, 2650
Not Yet Recruiting
Research Team
S
Sofie Ingdam Halkjær, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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