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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 6 Weeks
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Infants between the ages of 7 days and 6 weeks (+14 days in case of illness or COVID-19 related issues or unexpected delay in result reporting) at the time of randomisation. 2. A 10% or higher genetic risk to develop multiple beta-cell autoantibodies by age 6 years: 1. For infants without a first-degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8 or DR4-DQ8/DR4-DQ8 genotype and a genetic risk score that is in the upper 25th centile (>14.4) or a DR3/DR4-DQ8 genotype with a GRS between the upper 50th (14.0) and 25th centile and a GG genotype at the rs3763305 SNP. These represent around 1% of all newborns. 2. For infants with a first-degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1*1501, DQB1*0503, DRB1*1303. These represent around 30% of infants with a first-degree family history of T1D. 3. Written informed consent signed by the custodial parent(s).-

Exclusion Criteria:

1. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the Investigators. 2. Preterm delivery < 36 weeks of gestation. 3. Proven immunodeficiency. 4. Any condition that could be associated with poor compliance.5. Diagnosis of diabetes at the time of recruitment

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04769037
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Helmholtz Zentrum München
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOtherOtherOtherOtherOtherOtherOtherOther
Overall Status Recruiting
Countries Belgium, Germany, Poland, Sweden, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diabetes Mellitus, Type 1
Study Website: View Trial Website
Additional Details

The GPPAD-04 SINT1A study will evaluate whether early, regular supplementation with a daily dose of a probiotic can reduce the risk of developing beta-cell autoimmunity in children identified by GPPAD-02 as being genetically predisposed to developing type 1 diabetes. Children will be enrolled at age 7 days to 6 weeks (+14 days) and the study product (B. infantis EVC001 or Placebo) will be administered orally once per day from enrollment until age 12 months (+14 days). The hypotheses is that administration of B. infantis may have a positive influence on the intestinal flora and thus have a regulating effect on the immune system. The study is designed to investigate whether pathogenic immune reactions as in type 1 diabetes but also in other diseases, such as celiac disease, can be reduced and if the disease can be prevented. Children will be followed until age 3.5

  • - 6.5 years (2.5 - 5.5 years after end of treatment).
Throughout the study data will be collected by regular study visits, phone calls with the families and electronic questionaires. Blood samples will be collected to investigate glucose, HbA1c, beta-cell autoantibodies, transglutaminase antibodies, vaccine responses, genetic susceptibility and mechanistic markers. Stool samples will be collected for further assessments such as colonization,microbiome, pH and calprotectin. Exploratory outcomes (allergy, vaccine responses, stool microbiome, blood metabolomics, stool pH and calprotectin or site specific ancillary measurements) may be assessed or in part assessed on a portion of the participants after unblinding the study. They may not necessarily be included in the primary outcome analysis and publication. GPPAD is committed to sharing of data in compliance with all applicable European and GPPAD Consortium Member State, Data Protection and Privacy Protection laws, rules and regulations. Pseudonymized data of the GPPAD-04 SINT1A study will be available to the scientific community after the publication of the trial analysis, which is anticipated in 2028. The SINT1A data will be available upon request.

Arms & Interventions

Arms

Active Comparator: B. infantis

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

Placebo Comparator: Placebo

Lactose identical in appearance and taste to the active supplement

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Leuven, Belgium

Status

Recruiting

Address

University Hospitals Leuven Faculty of Medicine, Catholic University of Leuven

Leuven, ,

Site Contact

Kristina Casteels, Prof. Dr.

contact@gppad.org

+49-(0)800-000

Dresden, Germany

Status

Recruiting

Address

Universitätsklinikum Carl Gustav Carus Technische Universität Dresden

Dresden, ,

Site Contact

Reinhard Berner, Prof. Dr.

contact@gppad.org

+49-(0)800-000

Hannover, Germany

Status

Recruiting

Address

AUF DER BULT, Kinder- und Jugendkrankenhaus

Hannover, ,

Site Contact

Olga Kordonori, Prof. Dr.

contact@gppad.org

+49-(0)800-000

Munich, Germany

Status

Recruiting

Address

Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar

Munich, ,

Site Contact

Anette-G. Ziegler, Prof.Dr.med.

contact@gppad.org

+49-(0)800-000

Warsaw, Poland

Status

Recruiting

Address

Department of Paediatrics Medical University of Warsaw

Warsaw, ,

Site Contact

Agnieszka Szypowska, Prof. Dr.

contact@gppad.org

+49-(0)800-000

Malmö, Sweden

Status

Recruiting

Address

Lund University, Skane University Hospital SUS

Malmö, ,

Site Contact

Markus Lundgren, Dr.

contact@gppad.org

+49-(0)800-000

Cambridge, United Kingdom

Status

Not yet recruiting

Address

University Department of Paediatrics, Cambridge Biomedical Campus

Cambridge, ,

Site Contact

Loredana Marcovecchio, Dr.

contact@gppad.org

+49-(0)800-000

Newcastle, United Kingdom

Status

Not yet recruiting

Address

Royal Victoria Infirmary, Newcastle upon Tyne

Newcastle, ,

Site Contact

Catherine Owen, Dr.

contact@gppad.org

+49-(0)800-000

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