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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

RecruitingNAAges 1 Day - 7 DaysAllUniversity of Aarhus
NCT06452199 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B. infantis), given to healthy newborns can affect various health outcomes and to explore impacts of the infant gastrointestinal microbiome. The main questions it aims to answer are: * Does B. infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics? * Does B. infantis probiotics impact overall health, development, growth and wellbeing? * Does B. infantis probiotics impact inflammatory diseases, allergies and autoimmune diseases Researchers will compare B. infantis probiotics to a placebo (a look-alike substance that contains no probiotic) to see if B. infantis colonization impact the human immunesystem and various clinical and biochemical health markers.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • B. infantis
  • Placebo
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Where

2 sites
Regional Hospital Gødstrup
Herning, Denmark
Regional Hospital Horsens
Horsens, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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