Effects of Probiotics on Newborn Health and Growth
Official title: The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions
Run by University of Aarhus · NCT06452199 · Data updated 2026-11-12
This study is testing if giving a specific probiotic to healthy newborns can help boost their immune system, lower infections, and support their growth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 7 Days |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Herning, Central Jutland and 1 other locations) |
| Status | Recruiting |
| Started | June 10, 2024 |
| Main results expected | November 2026 |
| Study ends | November 2043 |
| Registry record updated | October 1, 2024 |
| Trial ID | NCT06452199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy infants born at term in the Region Midtjylland, Denmark.
✕Probably not a fit
Patients who may not benefit from this study include those with diagnosed immune deficiencies or other significant health conditions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The BEGIN Study is a randomized controlled trial investigating the effects of the probiotic Bifidobacterium longum subspecies infantis on healthy newborns. The study aims to determine whether administering this probiotic can enhance immune function, reduce bacterial infections, and improve overall health and growth in infants. Participants will receive either the probiotic or a placebo, and researchers will assess various health outcomes and the infant gastrointestinal microbiome. The study is conducted in the Region Midtjylland, Denmark, with parents administering the probiotic to their newborns.
Why it matters
Potential benefit: If successful, this study could lead to improved immune function and overall health in newborns, potentially reducing the incidence of infections and the need for antibiotics.
How similar studies have gone: Other studies have shown promising results with probiotics in infants, suggesting potential benefits in immune function and health outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born at term (above gestational week 37) * Infants born in Region Midtjylland Denmark receiving a Danish CPR number. * Parents age is above 18 * At least one parent holds a smartphone (for study app) and is able to fill out Danish questionaries * Both legal parents are willing and able to provide written informed consent prior to participation, regarding both themselves and their future child. Exclusion Criteria: * Multiple pregnancy * Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases * Parents expecting to give other probiotics
Where it's running
-
Regional Hospital Gødstrup
Herning, Central Jutland, Denmark Recruiting -
Regional Hospital Horsens
Horsens, Central Jutland, Denmark Recruiting
Study contacts
- Principal investigator: Sune Rubak, MD, Phd — Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University
- Study coordinator: Marie T Philipsen, MD, PhD.stud
- Email: marie.tholstrup@rm.dk
- Phone: +45 53637369
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.