Characterization of the Gastrointestinal Microbiota in Newborn Infants

Launched by HVIDOVRE UNIVERSITY HOSPITAL · Jan 17, 2025

Keywords

ClinConnect Summary

The BABIES study is a research trial looking at how a specific probiotic (a type of beneficial bacteria) can affect the gut health of newborn infants. The trial will involve healthy babies who are being monitored for four weeks after birth to see how well this probiotic can settle in their digestive system. Researchers will collect and analyze samples from the babies' stools to learn more about the probiotic's effects.

To participate in the study, pregnant individuals must be healthy, between 36 and 38 weeks pregnant, and plan to exclusively breastfeed. The newborns need to be born full-term, weigh more than 2500 grams, and have a good health score shortly after birth. Throughout the study, participants will receive either the probiotic or a placebo (a non-active substance) without knowing which one they are getting. This helps ensure that the results are reliable. If you or someone you know is interested in this study, it's a great opportunity to help advance understanding of infant health!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Inclusion Criteria for the pregnant person:
• • 1. Healthy pregnant person in gestational week 36+0-38+0
• • 2. Age ≥ 18 years
• • 3. Normal singleton pregnancy
• • 4. Ability to read and speak Danish
• • 5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks
• • 6. Plan to exclusively breastfeed
• • 7. Provided voluntary written informed consent.
• * Inclusions Criteria for the newborn:
• • 1. Born at full-term ≥37+0
• • 2. Birth weight above 2500 g
• • 3. APGAR score of at least 7 within the first 5 min of life.
• Exclusion Criteria:
• * Exclusion Criteria for the pregnant person:
• • 1. Pregnancy at over 38+0 weeks' gestation at recruitment
• • 2. Multiple pregnancy
• • 3. Pregnancy with any fetal abnormality
• • 4. Alcohol or drug abuse
• • 5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
• • 6. Any contraindications for breastfeeding.
• Exclusion Criteria for the newborn :
• • 1. Congenital disorders that could affect their safety or the study outcome
• • 2. Admission to Neonatal Intensive Care Unit for more than 24 hours
• • 3. Participation in another clinical intervention study which can interfere with this probiotic intervention
• • 4. No other probiotics than the study product.