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New treatment option for Healthy Infants
Official title Probiotic for Infants
ClinicalTrials.gov ID: NCT07054216
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 1. Healthy volunteers may be eligible.
You may be able to join if
- "" for the pregnant person
- 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
You likely can't join if
- " Exclusion Criteria for the pregnant person
- 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
- Pregnant person with any contraindications for breastfeeding. Exclusion Criteria for the newborn
See the full eligibility criteria
- "" for the pregnant person
- 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
- Provided voluntary written informed consent. Inclusions Criteria for the newborn
- Born at full-term ≥37+0
- Birth weight ≥ 2500 g
- APGAR score of ≥ 7 within the first 5 min of life. "
- " Exclusion Criteria for the pregnant person
- 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
- Pregnant person with any contraindications for breastfeeding. Exclusion Criteria for the newborn
- Congenital disorders that could affect their safety or the study outcome
- Admission to Neonatal Intensive Care Unit for more than 24 hours
- Participation in another clinical intervention study which can interfere with this probiotic intervention
- Probiotics other than the study product.
The study team makes the final eligibility decision.
Where it's taking place
- Hvidovre, Region Sjælland, Denmark
- Hvidovre, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 1 day. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hvidovre, Region Sjælland, Denmark; Hvidovre, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.