Probiotic for Infants
Launched by HVIDOVRE UNIVERSITY HOSPITAL · Jul 7, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called the BABIES II study, is looking at whether giving a special probiotic—a type of “good” bacteria—to healthy newborn babies can improve their health as they grow. The study will follow babies from about two weeks old until they are 9 months old, with additional check-ins up to 1 year and possibly even longer, up to 18 years. Researchers want to see if this probiotic helps with different health outcomes during infancy and beyond.
To take part, the baby’s pregnant parent needs to be at least 18 years old, expecting just one baby, planning to breastfeed, and able to understand Danish. The baby must be born full-term (at least 37 weeks), weigh at least 2.5 kilograms (about 5.5 pounds), and be healthy at birth. The study will not include babies with certain health issues or those who have been in intensive care for more than a day. If eligible, families can expect the baby to receive either the probiotic or a placebo (a harmless, inactive substance) without knowing which one, as the study is “double-blinded.” This means neither the parents nor the researchers will know who gets the probiotic until the study ends. The trial is not yet open for recruitment, and it will take place at Copenhagen University Hospital Hvidovre.
Gender
ALL
Eligibility criteria
- • "Inclusion Criteria"
- • Inclusion Criteria for the pregnant person
- • 1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
- • 2. Singleton pregnancy
- • 3. Ability to read and speak Danish
- • 4. Plan to breastfeed
- • 5. Provided voluntary written informed consent.
- • Inclusions Criteria for the newborn
- • 1. Born at full-term ≥37+0
- • 2. Birth weight ≥ 2500 g
- • 3. APGAR score of ≥ 7 within the first 5 min of life.
- • "Exclusion Criteria" Exclusion Criteria for the pregnant person
- • 1. Pregnancy at 38 weeks + 0 or later at the time of recruitment
- • 2. Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks
- • 3. Alcohol or drug abuse
- • 4. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
- • 5. Pregnant person with 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. Probiotics other than the study product.
About Hvidovre University Hospital
Hvidovre University Hospital is a leading clinical research institution located in Denmark, dedicated to advancing medical science through rigorous clinical trials and innovative healthcare solutions. As a prominent academic hospital, it integrates patient care with research, fostering collaboration among multidisciplinary teams of healthcare professionals, researchers, and academic institutions. Hvidovre University Hospital is committed to enhancing patient outcomes by conducting high-quality clinical studies across various therapeutic areas, ensuring adherence to ethical standards and regulatory compliance. Its state-of-the-art facilities and focus on translational medicine position the hospital as a key player in the development of new treatments and therapies, ultimately contributing to the improvement of public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hvidovre, , Denmark
Patients applied
Trial Officials
Andreas Munk Petersen, MD, PhD, DMSc
Principal Investigator
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported