Actively Recruiting

Phase Not Applicable
Age: 1Day - 7Days
All Genders
Healthy Volunteers
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

Led by University of Aarhus · Updated on 2024-10-01

1000

Participants Needed

2

Research Sites

1011 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Day - 7Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Regional Hospital Gødstrup

Herning, Central Jutland, Denmark, 7400

Actively Recruiting

2

Regional Hospital Horsens

Horsens, Central Jutland, Denmark, 8700

Actively Recruiting

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Research Team

M

Marie T Philipsen, MD, PhD.stud

CONTACT

M

Mia E Sjørring, MD, PhD.stud

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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