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
- Conditions
- HealthyHealthy Nutrition
- Interventions
- Dietary Supplement: B. infantisDietary Supplement: Placebo
- Registration Number
- NCT06452199
- Lead Sponsor
- University of Aarhus
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- Multiple pregnancy
- Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
- Parents expecting to give other probiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B. infantis B. infantis 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 Identical looking placebo.
- Primary Outcome Measures
Name Time Method Prescriptions of antibiotics First assessment at 1 year and up to 18 years follow-up Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.
- Secondary Outcome Measures
Name Time Method Bowel function, stool frequency. 3 months Parents' observations of their infant child's frequency of stool passings, registered in study app
Plasma Calprotectin 1 year Blood biomarker: Intestinal inflammation. Unit of measurement: µg/l
Bowel function, laxatives 3 months Parents' reported use of medical laxatives for their infant child, registered in study app and reported as amount of days using the laxative.
Allergies 1 year Self reported allergy symptoms
Growth, IGF-1 (Insulin-like Growth Factor-1) 1 year Blood biomarker: Mediating the growth-promoting effects of growth hormone. Unit of measurement: µg/l
Antibiotic resistance genes (ARGs) 1 year Amount of Antibiotic resistance genes (ARGs) in participants microbial community in stool samples. Identification with shutgun metagenomics. Assessing the microbial composition and diversity.
Colic 3 months 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.High sensitive C-reactive protein (hs-CRP) 1 year Blood biomarker: Low-grade systemic inflammation. Unit of measurement: mg/l
Cluster of Differentiation 163" (CD163) 1 year Blood biomarker: Macrophage-mediated inflammation and insulin-sensitivity. Unit of measurement: mg/l
Allergies, Immunoglobulin E (IgE) 1 year 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
Growth First assessment at 1 year and up to 18 years follow-up Growth velocity and weight-for-length z-scores, measured in kilograms and centimeters and combined for Z-scores.
The intestinal microbiota and B. infantis colonization 1 year Stool samples collected during the first year of life and tested with shutgun metagenomics, assessing the microbial composition..
Bowel function, stool consistency 3 months Parents' observations registered in study app, related to their infant child's stool consistency measured at the Infant Stool Scale
Growth, weight gain First assessment at 1 year and up to 18 years follow-up Measured as weight gain in kilograms
Body composition 3 months Measured by air displacement plethysmography (ADP) (Pea Pod) estimating muscle mass.
Trial Locations
- Locations (2)
Regional Hospital Gødstrup
🇩🇰Herning, Midtjylland, Denmark
Regional Hospital Horsens
🇩🇰Horsens, Midtjylland, Denmark