Exploring the gut bacteria in newborn infants
Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
This study tests if giving a specific probiotic to healthy newborns for four weeks can help improve their gut bacteria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 1 Day |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06789484 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include healthy pregnant individuals in their late third trimester planning to exclusively breastfeed and their full-term newborns.
Not a fit: Patients with congenital disorders or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of infant gut health and potentially improve dietary recommendations for newborns.
How similar studies have performed: Previous studies on probiotics in infants have shown promising results, indicating potential benefits in gut health, making this approach both relevant and supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hvidovre
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.