Exploring the gut bacteria in newborn infants

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 study investigates the gastrointestinal microbiota in healthy newborn infants by supplementing them with a specific probiotic strain for four weeks. It is a randomized, double-blinded, placebo-controlled trial conducted at Hvidovre University Hospital. The primary goal is to assess how well the probiotic strain can establish itself in the infants' gut, measured through fecal samples analyzed with quantitative Polymerase Chain Reaction (qPCR). Following the intervention, there will be a two-week follow-up period to monitor the effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
  Hvidovre, Denmark 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: +4541318174

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dietary supplement in healthy infants

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• Daily probiotic supplement for healthy newborns

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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.