Actively 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
Led by University of Aarhus · Updated on 2024-10-01
1000
Participants Needed
2
Research Sites
1011 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Multiple pregnancy
- Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
- Parents expecting to give other probiotics
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Regional Hospital Gødstrup
Herning, Central Jutland, Denmark, 7400
Actively Recruiting
2
Regional Hospital Horsens
Horsens, Central Jutland, Denmark, 8700
Actively Recruiting
Research Team
M
Marie T Philipsen, MD, PhD.stud
CONTACT
M
Mia E Sjørring, MD, PhD.stud
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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