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Study identifier: NCT06452199 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Healthy · Healthy Nutrition  ·  Sponsor: University of Aarhus

PhaseNA
Planned participants1000
Who can joinAll sexes, 1 Day to 7 Days
Healthy volunteersYes

About this study

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. Participants (parents) will * Orally administrate the B. infantis probiotic to their newborn child daily in three weeks from 7 days of age. * Answer baseline and follow up questionnaires in a study app * Take five stool samples from the child and one stool sample from the mother * Collect a 4 week of passive dust sample at home (Electrostatic Dust fall Collector) * Donate one dried bloodspot and one blood sample from their child

This description comes directly from the study's public registry record.

Talk to the study team

Marie T Philipsen, MD, PhD.stud  ·  +45 53637369  ·  marie.tholstrup@rm.dk

Mia E Sjørring, MD, PhD.stud  ·  60199810  ·  miasoe@rm.dk

Always discuss trial participation with your own doctor first.

Locations (2)

Regional Hospital GødstrupHerning, Central Jutland, DenmarkRecruiting
Regional Hospital HorsensHorsens, Central Jutland, DenmarkRecruiting

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Source record: clinicaltrials.gov/study/NCT06452199