The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial
Launched by UNIVERSITY OF AARHUS · Jun 10, 2024
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
The BEGIN Study is a clinical trial aimed at understanding how a specific probiotic called Bifidobacterium infantis (B. infantis) can benefit healthy newborns. Researchers want to see if giving this probiotic can help improve the baby’s immune system, reduce infections and the need for antibiotics, and positively influence their overall growth and health. They will compare the effects of B. infantis with a placebo, which looks the same but contains no active ingredient, to see how it affects various health markers in babies.
To participate, infants must be born healthy and full-term (after 37 weeks of pregnancy) and live in a specific region of Denmark. Parents should be over 18 and willing to use a smartphone app for the study, answer questions, and provide some samples (like stool and blood) from their baby. Participants will give the probiotic daily for three weeks, and researchers will track how it impacts the babies’ health and development. This study is currently recruiting participants, and it’s important for parents to be aware that certain health conditions or the use of other probiotics may exclude their child from participating.
Gender
ALL
Eligibility 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
About University Of Aarhus
The University of Aarhus, a prestigious research institution located in Denmark, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages cutting-edge research and the development of novel therapeutic interventions. Committed to ethical standards and patient safety, the University of Aarhus aims to contribute to the global body of medical knowledge while enhancing healthcare outcomes through rigorous scientific inquiry and evidence-based practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Herning, Midtjylland, Denmark
Horsens, Midtjylland, Denmark
Patients applied
Trial Officials
Sune Rubak, MD, Phd
Principal Investigator
Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University
Kurt Kristensen, MD, Phd
Principal Investigator
Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported