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

Last updated: September 30, 2024
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

B. infantis

Placebo

Clinical Study ID

NCT06452199
BEGIN 2024
  • Ages 1-7
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 outDanish questionaries

  • Both legal parents are willing and able to provide written informed consent prior toparticipation, regarding both themselves and their future child.

Exclusion

Exclusion Criteria:

  • Multiple pregnancy

  • Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, orendocrine diseases

  • Parents expecting to give other probiotics

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: B. infantis
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
November 30, 2043

Connect with a study center

  • Regional Hospital Gødstrup

    Herning, Midtjylland 7400
    Denmark

    Active - Recruiting

  • Regional Hospital Horsens

    Horsens, Midtjylland 8700
    Denmark

    Active - Recruiting

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