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
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
Multiple pregnancy
Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
Parents expecting to give other probiotics
Parallel
B. infantis
Dietary supplement1000 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.
Placebo
Dietary supplementIdentical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age.
Prescriptions of antibiotics
Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.
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..
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.
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.
Bowel function, stool consistency
Parents' observations registered in study app, related to their infant child's stool consistency measured at the Infant Stool Scale
Hospital admissions
Number of hospital admissions. Registered at Landspatientregistret
Febrile episodes
Number of days with a fever during the last month. A febrile episode is characterized as a body temperature at 38 degrees Celsius or above. Self-reported in a monthly questionnaire in study app.
Asthma Control Test
Participants reporting symptoms of astma or astmatic bronkitis, will be asked to complete the Asthma Control Test. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
Asthmatic Bronchitis, prescriptions
Number of prescriptions of medicine for asthmatic bronchitis; Ventoline, Airomir, Flixotide, Aerobec, Montelukast / Singulair.
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Gødstrup Hospital
Collaborator
Regionshospitalet Horsens
Collaborator
Technical University of Denmark
Collaborator
Statens Serum Institut
Collaborator
University of Copenhagen
Collaborator
