NCT06789484 Characterization of the Gastrointestinal Microbiota in Newborn Infants
| NCT ID | NCT06789484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hvidovre University Hospital |
| Condition | Healthy Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-04 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 40 participants in total. It began in 2025-03-04 with a primary completion date of 2025-10-30.
⚠ 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 study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain. The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
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.
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 NCT06789484 clinical trial?
This trial is open to participants of all sexes, 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 NCT06789484 currently recruiting?
Yes, NCT06789484 is actively recruiting participants. Contact the research team at sofie.ingdam.halkjaer@regionh.dk for enrollment information.
Where is the NCT06789484 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT06789484 clinical trial?
NCT06789484 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 40 participants.