Daily probiotic supplement for healthy newborns

Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study

We're testing whether giving a daily probiotic to healthy newborns from about two weeks to nine months helps their gut microbiome and overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 378 (estimated)
• Ages: 0 Days to 1 Day
• Sex: All
• Sponsor: Hvidovre University Hospital (Academic / other)
• Locations: 2 sites (Hvidovre, Region Sjælland and 1 other locations)
• Trial ID: NCT07054216 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled trial that gives either a probiotic or a placebo to newborns from 14 days of age until nine months. Mothers are recruited in late pregnancy and infants are enrolled if born at term with normal birthweight and APGAR scores. Participants receive the assigned product daily for 8½ months, with a short follow-up to one year and a possible long-term follow-up to 18 years. The study compares health outcomes and gut microbiome changes between the probiotic and placebo groups.

Who should consider this trial

Good fit: Healthy full-term infants born at Hvidovre Hospital (birth ≥37 weeks, weight ≥2500 g, 5-minute APGAR ≥7) whose mothers are 18+ years, plan to breastfeed, and can read/speak Danish are ideal candidates.

Not a fit: Infants with congenital disorders, those admitted to the neonatal intensive care unit, preterm or low‑birthweight babies, or families who do not plan to breastfeed or deliver at the study hospital are unlikely to benefit or qualify.

Why it matters

Potential benefit: If successful, this could provide an easy early-life intervention to improve infants' gut microbiome and potentially lower the risk of some gastrointestinal problems or infections.

How similar studies have performed: Some prior trials have shown probiotic benefits for specific outcomes (for example reduced NEC in preterm infants or measurable microbiome changes), but results in healthy full-term infants are mixed and not yet conclusive.

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.

Where this trial is running

Hvidovre, Region Sjælland and 1 other locations

• Hvidovre Hospital — Hvidovre, Region Sjælland, Denmark (Recruiting)
• Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling — Hvidovre, Denmark (Not_yet_recruiting)

Study contacts

• Principal investigator: Andreas Munk Petersen, MD, PhD, DMSc — Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
• Study coordinator: Sofie Ingdam Halkjær, MSc, PhD

Conditions Healthy Infants; Infant; Gastrointestinal Microbiome; Diet, Food, and Nutrition