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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Gødstrup Hospital | OTHER |
| Regionshospitalet Horsens | OTHER |
| Technical University of Denmark |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B. infantis | Active Comparator | The investigational product to be tested is a Probio-Tec® I Stick-0.16 IF, containing 1.0 g of a standardized fine powder consisting of a food constituent, the freeze-dried culture of Bifidobacterium longum subsp. infantis Bifin02 (DSM33361). The infant dietary supplement is supposed to be mixed with a little human milk or clean water. |
|
| Placebo | Placebo Comparator | Identical looking placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. infantis | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prescriptions of antibiotics | Number of prescriptions of antibiotics among participants, as a measure of bacterial infections. | First assessment at 1 year and up to 18 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. | 1 year |
| Antibiotic resistance genes (ARGs) |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admissions | Number of hospital admissions. Registered at Landspatientregistret | First assessment at 1 year and up to 18 years follow-up |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie T Philipsen, MD, PhD.stud | Contact | +45 53637369 | marie.tholstrup@rm.dk | |
| Mia E Sjørring, MD, PhD.stud | Contact | 60199810 | miasoe@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Sune Rubak, MD, Phd | Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University | Principal Investigator |
| Kurt Kristensen, MD, Phd | Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Gødstrup | Recruiting | Herning | Central Jutland | 7400 | Denmark |
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| Label | URL |
|---|---|
| studywebsite for participants | View source |
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Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices).
The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).
After the study has been finalized
Researchers who provide a methodologically sound proposal.
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| OTHER |
| Statens Serum Institut | OTHER |
| University of Copenhagen | OTHER |
Randomised controlled double-blinded intervention trial
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|
| Placebo | Dietary Supplement | Identical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age. |
|
Amount of Antibiotic resistance genes (ARGs) in participants microbial community in stool samples. Identification with shutgun metagenomics. Assessing the microbial composition and diversity.
| 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. | 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 | 3 months |
| Bowel function, stool frequency. | Parents' observations of their infant child's frequency of stool passings, registered in study app | 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. | 3 months |
| High sensitive C-reactive protein (hs-CRP) | Blood biomarker: Low-grade systemic inflammation. Unit of measurement: mg/l | 1 year |
| Cluster of Differentiation 163" (CD163) | Blood biomarker: Macrophage-mediated inflammation and insulin-sensitivity. Unit of measurement: mg/l | 1 year |
| Plasma Calprotectin | Blood biomarker: Intestinal inflammation. Unit of measurement: µg/l | 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 | 1 year |
| Allergies | Self reported allergy symptoms | 1 year |
| Growth, weight gain | Measured as weight gain in kilograms | 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. | 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 | 1 year |
| Body composition | Measured by air displacement plethysmography (ADP) (Pea Pod) estimating body fat | 3 months |
| Body composition | Measured by air displacement plethysmography (ADP) (Pea Pod) estimating muscle mass. | 3 months |
| 1 year |
| 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. | 1 year, possible later follow-up |
| Asthmatic Bronchitis, prescriptions | Number of prescriptions of medicine for asthmatic bronchitis; Ventoline, Airomir, Flixotide, Aerobec, Montelukast / Singulair. | First assessment at 1 year |
| Asthmatic bronchitis, hospitalization | Number of hospitalizations due to asthmatic bronchitis. | First assessment at 1 year |
| Diaper rash | Atopic skin symptoms in diaper area. Self-reported by the childs parents as affected red skin, distribution in centimeters . | 1 year |
| Rhinoconjunctivitis | 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. | 1 year |
| Obesity | Measured as number of participants diagnosed with Obesity | 18 years |
| Metabolic syndrome | Measured as number of participants diagnosed with Metabolic syndrome | 18 years |
| Diabetes | Measured as number of participants diagnosed with Diabetes | 18 years |
| Inflammatory bowel disease | Measured as number of participants diagnosed with of Morbus Crohn and/or Colitis Ulcerosa. | 18 years |
| Dried blood spot for metabolomics | The metabolomic method measures and compares large numbers of metabolites (for example shot chained fatty acids) present in the dried blood sample. | 3 months and 1 year |
| Bloodsample analyzed with Singlecell PBMC method | Single cell sequencing is a method profiling the peripheral blood mononuclear cells (PBMC), by isolating memory B, T and B-cells | 1 year |
| Child stool sample | Stool samples collected at week 1, 4, 13, 28 and 52 will by qPCR or shutgun metagenomics examine the gut microbiome. | 1 year |
| Mother stool sample | 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. | 1 month |
| Mother HMO-secretor status | 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. | 1 month |
| Asthma | Number of participants with prescriptions of medicine for asthma | up to 18 years follow-up |
| Atopic disease (adjusted SCORAD grading) | 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. | First assessment at 1 year |
| Atopic disease, local steroids | Number of participants with prescriptions of local steroids to treat eczema. | First assessment at 1 year and up to 18 years follow-up |
| Regional Hospital Horsens | Recruiting | Horsens | Central Jutland | 8700 | Denmark |
|
| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| D003085 | Colic |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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