| NCT ID | NCT07054216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hvidovre University Hospital |
| Condition | Healthy Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 378 participants in total. It began in 2025-08-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
"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.
Contact & Investigator
Andreas Munk Petersen, MD, PhD, DMSc
PRINCIPAL INVESTIGATOR
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
Frequently Asked Questions
Who can join the NCT07054216 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 1 Day, studying Healthy Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07054216 currently recruiting?
Yes, NCT07054216 is actively recruiting participants. Contact the research team at sofie.ingdam.halkjaer@regionh.dk for enrollment information.
Where is the NCT07054216 trial being conducted?
This trial is being conducted at Hvidovre, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT07054216 clinical trial?
NCT07054216 is sponsored by Hvidovre University Hospital. The principal investigator is Andreas Munk Petersen, MD, PhD, DMSc at Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital. The trial plans to enroll 378 participants.