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Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity

NCT04769037 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1149

Last updated 2024-12-13

No results posted yet for this study

Summary

Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DIETARY_SUPPLEMENT

B. infantis

Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day

DIETARY_SUPPLEMENT

Placebo

Lactose identical in appearance and taste to the active supplement

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER

  • Kinderkrankenhaus auf der Bult

    collaborator OTHER

  • University Hospital Carl Gustav Carus

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Medical University of Warsaw

    collaborator OTHER

  • Cambridge Biomedical Campus, Cambridge, UK

    collaborator UNKNOWN

  • Royal Victoria Infirmary, Newcastle upon Tyne, UK

    collaborator UNKNOWN

  • Helmholtz Zentrum München

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
6 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Belgium
  • Germany
  • Poland
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04769037 on ClinicalTrials.gov