Clinical trial NCT06452199: 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
Official title: The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Healthy Nutrition
Keywords: Microbiota
Gastrointestinal Microbiome
Probiotics
Bifidobacterium longum subspecies infantis
Paediatrics
Infant
Child
Immunology
Infections
Inflammation
Growth and Development
Colic
Respiratory Tract Diseases
Metabolism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Gødstrup Hospital
name: Regionshospitalet Horsens
name: Technical University of Denmark
name: Statens Serum Institut
name: University of Copenhagen
First posted: 2024-06-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled double-blinded intervention trial
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Multiple pregnancy
* Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
* Parents expecting to give other probiotics

Primary outcomes:
measure: Prescriptions of antibiotics
timeFrame: First assessment at 1 year and up to 18 years follow-up
Secondary outcomes:
measure: The intestinal microbiota and B. infantis colonization
timeFrame: 1 year
measure: Antibiotic resistance genes (ARGs)
timeFrame: 1 year
measure: Colic
timeFrame: 3 months
measure: Bowel function, stool consistency
timeFrame: 3 months
measure: Bowel function, stool frequency.
timeFrame: 3 months
measure: Bowel function, laxatives
timeFrame: 3 months
measure: High sensitive C-reactive protein (hs-CRP)
timeFrame: 1 year
measure: Cluster of Differentiation 163" (CD163)
timeFrame: 1 year
measure: Plasma Calprotectin
timeFrame: 1 year
measure: Allergies, Immunoglobulin E (IgE)
timeFrame: 1 year
measure: Allergies
timeFrame: 1 year
measure: Growth, weight gain
timeFrame: First assessment at 1 year and up to 18 years follow-up
measure: Growth
timeFrame: First assessment at 1 year and up to 18 years follow-up
measure: Growth, IGF-1 (Insulin-like Growth Factor-1)
timeFrame: 1 year
measure: Body composition
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
Other outcomes:
measure: Hospital admissions
timeFrame: First assessment at 1 year and up to 18 years follow-up
measure: Febrile episodes
timeFrame: 1 year
measure: Asthma Control Test
timeFrame: 1 year, possible later follow-up
measure: Asthmatic Bronchitis, prescriptions
timeFrame: First assessment at 1 year
measure: Asthmatic bronchitis, hospitalization
timeFrame: First assessment at 1 year
measure: Diaper rash
timeFrame: 1 year
measure: Rhinoconjunctivitis
timeFrame: 1 year
measure: Obesity
timeFrame: 18 years
measure: Metabolic syndrome
timeFrame: 18 years
measure: Diabetes
timeFrame: 18 years
measure: Inflammatory bowel disease
timeFrame: 18 years
measure: Dried blood spot for metabolomics
timeFrame: 3 months and 1 year
measure: Bloodsample analyzed with Singlecell PBMC method
timeFrame: 1 year
measure: Child stool sample
timeFrame: 1 year
measure: Mother stool sample
timeFrame: 1 month
measure: Mother HMO-secretor status
timeFrame: 1 month
measure: Asthma
timeFrame: up to 18 years follow-up
measure: Atopic disease (adjusted SCORAD grading)
timeFrame: First assessment at 1 year
measure: Atopic disease, local steroids
timeFrame: First assessment at 1 year and up to 18 years follow-up
Locations:
city: Herning
country: Denmark
facility: Regional Hospital Gødstrup
state: Midtjylland
city: Horsens
country: Denmark
facility: Regional Hospital Horsens
state: Midtjylland
Study officials:
affiliation: Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University
name: Sune Rubak, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University
name: Kurt Kristensen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: