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

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

Conditions

• Healthy
• Healthy Nutrition

Interventions

DIETARY_SUPPLEMENT

B. infantis

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.

DIETARY_SUPPLEMENT

Placebo

Identical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Regionshospitalet Horsens

  collaborator OTHER

• Technical University of Denmark

  collaborator OTHER

• Statens Serum Institut

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Sune Rubak, MD, Phd · Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University

• Kurt Kristensen, MD, Phd · Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

7 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-10

Primary Completion

2026-11-30

Completion

2043-11-30

Countries

• Denmark

Study Locations