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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
NCT06452199 · University of Aarhus
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions
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
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
Study design
Enrollment target: 1000 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2024-06-10
Estimated completion: 2043-11
Last updated: 2024-10-01
Interventions
Dietary Supplement: B. infantisDietary Supplement: Placebo
Primary outcomes
- • Prescriptions of antibiotics (First assessment at 1 year and up to 18 years follow-up)
Sponsor
University of Aarhus · other
With: Aarhus University Hospital, Gødstrup Hospital, Regionshospitalet Horsens, Technical University of Denmark, Statens Serum Institut, University of Copenhagen
Contacts & investigators
ContactMarie T Philipsen, MD, PhD.stud · contact · marie.tholstrup@rm.dk · +45 53637369
ContactMia E Sjørring, MD, PhD.stud · contact · miasoe@rm.dk · 60199810
InvestigatorSune Rubak, MD, Phd · principal_investigator, Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University
InvestigatorKurt Kristensen, MD, Phd · principal_investigator, Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University
All locations (2)
Regional Hospital GødstrupRecruiting
Herning, Central Jutland, Denmark
Regional Hospital HorsensRecruiting
Horsens, Central Jutland, Denmark