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

Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.

Stool samples collected during the first year of life and tested with shutgun metagenomics, assessing the microbial composition..

Amount of Antibiotic resistance genes (ARGs) in participants microbial community in stool samples. Identification with shutgun metagenomics. Assessing the microbial composition and diversity.

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.

Parents' observations registered in study app, related to their infant child's stool consistency measured at the Infant Stool Scale

Parents' observations of their infant child's frequency of stool passings, registered in study app

Parents' reported use of medical laxatives for their infant child, registered in study app and reported as amount of days using the laxative.

Blood biomarker: Low-grade systemic inflammation. Unit of measurement: mg/l

Blood biomarker: Macrophage-mediated inflammation and insulin-sensitivity. Unit of measurement: mg/l

Blood biomarker: Intestinal inflammation. Unit of measurement: µg/l

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

Self reported allergy symptoms

Measured as weight gain in kilograms

Growth velocity and weight-for-length z-scores, measured in kilograms and centimeters and combined for Z-scores.

Blood biomarker: Mediating the growth-promoting effects of growth hormone. Unit of measurement: µg/l

Measured by air displacement plethysmography (ADP) (Pea Pod) estimating body fat

Measured by air displacement plethysmography (ADP) (Pea Pod) estimating muscle mass.

Number of hospital admissions. Registered at Landspatientregistret

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.

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.

Number of prescriptions of medicine for asthmatic bronchitis; Ventoline, Airomir, Flixotide, Aerobec, Montelukast / Singulair.

Number of hospitalizations due to asthmatic bronchitis.

Atopic skin symptoms in diaper area. Self-reported by the childs parents as affected red skin, distribution in centimeters .

Measured as Mini Rhinoconjunctivitis quality of life questionnaire Mini RQLQ, adjusted to infants. 14 questions in five domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/ eye symptoms), scores for each question is ranging from 0 to 6, with 0 reflecting no affection and 6 reflecting maximum affection.

Measured as number of participants diagnosed with Obesity

Measured as number of participants diagnosed with Metabolic syndrome

Measured as number of participants diagnosed with Diabetes

Measured as number of participants diagnosed with of Morbus Crohn and/or Colitis Ulcerosa.

The metabolomic method measures and compares large numbers of metabolites (for example shot chained fatty acids) present in the dried blood sample.

Single cell sequencing is a method profiling the peripheral blood mononuclear cells (PBMC), by isolating memory B, T and B-cells

Stool samples collected at week 1, 4, 13, 28 and 52 will by qPCR or shutgun metagenomics examine the gut microbiome.

A stool sample from the pregnant mother, preferably prior to or during birth. To analyze mothers microbial colonization, that may be transferred to the child, e.g during vaginal birth.

The type of Human Milk Oligosaccharides (HMO) section in mothers' breastmilk, will be determined to exploratively study the relationship between types of HMO's, mothers HMO-secretor status and effects of B.infantis.

Number of participants with prescriptions of medicine for asthma

Atopic symptoms, eczema, registered in study-app with description of episodes of atopic dermatitis (adjusted SCORAD grading). Disease intensity is calculated based on six characteristics: erythema, edema, oozing/crusts, excoriations, lichenification, and dryness. Each characteristic is given a score between 0 and 3, where 0 is absent and 3 is severe. The scores for each characteristic are added together for a total intensity score of up to 18.

Number of participants with prescriptions of local steroids to treat eczema.