Daily probiotic supplement for healthy newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

"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 it's running

• 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
• Email: sofie.ingdam.halkjaer@regionh.dk
• Phone: +45 38 62 38 62

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.