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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,000
1000 newborn children are randomized 50/50 to receive either B. infanits or placebo in a dietary supplement, for daily oral administration in three weeks from 7 days of age.
Identical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age.
Regional Hospital Gødstrup
Herning, Central Jutland, Denmark
RECRUITINGRegional Hospital Horsens
Horsens, Central Jutland, Denmark
RECRUITINGPrescriptions of antibiotics
Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.
Time frame: First assessment at 1 year and up to 18 years follow-up
The intestinal microbiota and B. infantis colonization
Stool samples collected during the first year of life and tested with shutgun metagenomics, assessing the microbial composition..
Time frame: 1 year
Antibiotic resistance genes (ARGs)
Amount of Antibiotic resistance genes (ARGs) in participants microbial community in stool samples. Identification with shutgun metagenomics. Assessing the microbial composition and diversity.
Time frame: 1 year
Colic
Parents' observations registered in study app. Duration of crying in the first three months of life. Defined as Wessels criteria: Crying for three or more hours a day, three or more days a week, for three or more weeks.
Time frame: 3 months
Bowel function, stool consistency
Parents' observations registered in study app, related to their infant child's stool consistency measured at the Infant Stool Scale
Time frame: 3 months
Bowel function, stool frequency.
Parents' observations of their infant child's frequency of stool passings, registered in study app
Time frame: 3 months
Bowel function, laxatives
Parents' reported use of medical laxatives for their infant child, registered in study app and reported as amount of days using the laxative.
Time frame: 3 months
High sensitive C-reactive protein (hs-CRP)
Blood biomarker: Low-grade systemic inflammation. Unit of measurement: mg/l
Time frame: 1 year
Cluster of Differentiation 163" (CD163)
Blood biomarker: Macrophage-mediated inflammation and insulin-sensitivity. Unit of measurement: mg/l
Time frame: 1 year
Plasma Calprotectin
Blood biomarker: Intestinal inflammation. Unit of measurement: µg/l
Time frame: 1 year
Allergies, Immunoglobulin E (IgE)
Blood marker: Allergies. Specific IgE against the 11 most common inhalation allergens and IgE directed against Egg white, cow's milk, codfish, wheat, peanut and soybean. Unit of measurement: IU/l
Time frame: 1 year
Allergies
Self reported allergy symptoms
Time frame: 1 year
Growth, weight gain
Measured as weight gain in kilograms
Time frame: First assessment at 1 year and up to 18 years follow-up
Growth
Growth velocity and weight-for-length z-scores, measured in kilograms and centimeters and combined for Z-scores.
Time frame: First assessment at 1 year and up to 18 years follow-up
Growth, IGF-1 (Insulin-like Growth Factor-1)
Blood biomarker: Mediating the growth-promoting effects of growth hormone. Unit of measurement: µg/l
Time frame: 1 year
Body composition
Measured by air displacement plethysmography (ADP) (Pea Pod) estimating body fat
Time frame: 3 months
Body composition
Measured by air displacement plethysmography (ADP) (Pea Pod) estimating muscle mass.
Time frame: 3 months
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