NCT06452199

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable healthy

Timeline
213mo left

Started Jun 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2024Nov 2043

First Submitted

Initial submission to the registry

May 22, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
17 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2043

Last Updated

October 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

May 22, 2024

Last Update Submit

September 30, 2024

Conditions

HealthyHealthy Nutrition

Keywords

MicrobiotaGastrointestinal MicrobiomeProbioticsBifidobacterium longum subspecies infantisPaediatricsInfantChildImmunologyInfectionsInflammationGrowth and DevelopmentColicRespiratory Tract DiseasesMetabolism

Outcome Measures

Primary Outcomes (1)

  • Prescriptions of antibiotics

    Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.

    First assessment at 1 year and up to 18 years follow-up

Secondary Outcomes (16)

  • The intestinal microbiota and B. infantis colonization

    1 year

  • Antibiotic resistance genes (ARGs)

    1 year

  • Colic

    3 months

  • Bowel function, stool consistency

    3 months

  • Bowel function, stool frequency.

    3 months

  • +11 more secondary outcomes

Other Outcomes (19)

  • Hospital admissions

    First assessment at 1 year and up to 18 years follow-up

  • Febrile episodes

    1 year

  • Asthma Control Test

    1 year, possible later follow-up

  • +16 more other outcomes

Study Arms (2)

B. infantis

ACTIVE COMPARATOR

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.

Dietary Supplement: B. infantis

Placebo

PLACEBO COMPARATOR

Identical looking placebo.

Dietary Supplement: Placebo

Interventions

B. infantisDIETARY_SUPPLEMENT

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.

Also known as: Bifidobacterium longum subsp. infantis Bifin02 (DSM33361)
B. infantis
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regional Hospital Gødstrup

Herning, Central Jutland, 7400, Denmark

RECRUITING

Regional Hospital Horsens

Horsens, Central Jutland, 8700, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

InfectionsInflammationColicRespiratory Tract Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sune Rubak, MD, Phd

    Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University

    PRINCIPAL INVESTIGATOR

  • Kurt Kristensen, MD, Phd

    Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie T Philipsen, MD, PhD.stud

CONTACT

+45 53637369marie.tholstrup@rm.dk

Mia E Sjørring, MD, PhD.stud

CONTACT

60199810miasoe@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled double-blinded intervention trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 11, 2024

Study Start

June 10, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2043

Last Updated

October 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices). The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the study has been finalized
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

DK(2)