Supplementation with B. infantis to mitigate Type 1 Diabetes Autoimmunity

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Project created: 13th Jul 2026

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Id of the project(*) : NCT04769037

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : "SINT1A" - Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity - A Study of the Global Platform for the Prevention of Autoimmune Diabetes ("GPPAD")
Language of the title/name : English

Title/name : Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
Language of the title/name : English

Acronym(s) of the Project

Acronym : SINT1A
Language of the acronym : English

Description(s) of the Project

Description : 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Type 1 diabetes autoimmunity

Keyword(*) : celiac autoimmunity

Keyword(*) : respiratory infections

Keyword(*) : allergy

Keyword(*) : prevention

Keyword(*) : probiotic

Keyword(*) : B. infantis

Keyword(*) : Diabetes Mellitus, Type 1

Keyword(*) : Respiratory Tract Infections

Keyword(*) : Hypersensitivity

Keyword(*) : Diabetes Mellitus

Keyword(*) : Glucose Metabolism Disorders

Keyword(*) : Metabolic Diseases

Keyword(*) : Nutritional and Metabolic Diseases

Keyword(*) : Endocrine System Diseases

Keyword(*) : Autoimmune Diseases

Keyword(*) : Immune System Diseases

Keyword(*) : Infections

Keyword(*) : Respiratory Tract Diseases

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Other
Given name(*) : Anette-Gabriele
Family name(s)(*) : Ziegler
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Email address : Not specified
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Helmholtz Zentrum München
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Technical University of Munich
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
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Name of the organisation/institution/group(*) : Kinderkrankenhaus auf der Bult
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : University Hospital Carl Gustav Carus
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Skane University Hospital
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitaire Ziekenhuizen KU Leuven
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Is it a personal or organisational contribution?(*) : Organisational
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Contributor type(*) : Other
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Name of the organisation/institution/group(*) : Medical University of Warsaw
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Is it a personal or organisational contribution?(*) : Organisational
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Contributor type(*) : Other
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Name of the organisation/institution/group(*) : Cambridge Biomedical Campus, Cambridge, UK
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Royal Victoria Infirmary, Newcastle upon Tyne, UK
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Creator/Author
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Helmholtz Zentrum München
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Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT04769037

Type of the registry(*) : Other
Identifier(*) : GPPAD-04

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Diabetes Mellitus, Type 1
Terminology/classification(*) : Free text
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Unknown
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Not specified
Overall Project status : Ongoing (III): Recruitment completed, but data collection ongoing
Participants enrolled by invitation? : Not specified
Start date : 22 April 2021
End date : 1 October 2027
Mono- or multicentric? : Multicentric
Number of centers : 8
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
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
Population of the Project(*)
Coverage : Not specified
Country(ies) : Germany
Region(s) and/or city(ies) : - University Hospitals Leuven Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium- Universitätsklinikum Carl Gustav Carus Technische Universität Dresden, Dresden, Germany- AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany- Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar, Munich, Germany- Department of Paediatrics Medical University of Warsaw, Warsaw, Poland- Lund University, Skane University Hospital SUS, Malmö, Sweden- University Department of Paediatrics, Cambridge Biomedical Campus, Cambridge, United Kingdom- Royal Victoria Infirmary, Newcastle upon Tyne, Newcastle, United Kingdom
Interventions of the Project
Name of the intervention(*) : B. infantis
Type of the intervention : Dietary supplement (e.g., vitamins, minerals)
Additional information about the intervention : Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day
Name(s) of the arm(s) associated with the given intervention : B. infantis
Name of the intervention(*) : Placebo
Type of the intervention : Dietary supplement (e.g., vitamins, minerals)
Additional information about the intervention : Lactose identical in appearance and taste to the active supplement
Name(s) of the arm(s) associated with the given intervention : Placebo
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Persistent confirmed multiple beta-cell autoantibodies
Description of the outcome measure : Persistent confirmed multiple beta-cell autoantibodies is defined as confirmed IAA, confirmed GADA, confirmed IA-2A, or confirmed ZnT8A in two consecutive samples, AND a confirmed second antibody from these four antibodies in one sample.The primary outcome is the elapsed time from the random treatment assignment to the first confirmed autoantibody positive sample used in defining the persistent confirmed multiple beta-cell autoantibody positive status. Diabetes in the absence of multiple beta-cell autoantibodies is also considered as a primary outcome endpoint, and in this case, the date of diagnosis is the time of the end point.
Type of the outcome measure : Primary
Time point(s) of assessment : Through study completion, up to 6.5 years
Name of the outcome measure(*) : Persistent confirmed beta-cell autoantibodies
Description of the outcome measure : Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including IAA, GADA, IA-2A or ZnT8A
Type of the outcome measure : Secondary
Time point(s) of assessment : Through study completion, up to 6.5 years
Name of the outcome measure(*) : Diabetes
Description of the outcome measure : Criteria for T1D onset are, as defined by the American Diabetes Association (ADA), based on glucose testing, or the presence of unequivocal hyperglycaemia with acute metabolic decompensation (diabetic ketoacidosis).
Type of the outcome measure : Secondary
Time point(s) of assessment : Through study completion, up to 6.5 years
Name of the outcome measure(*) : Transglutaminase antibodies
Description of the outcome measure : Transglutaminase antibodies defined as persistent in two consecutive samples
Type of the outcome measure : Secondary
Time point(s) of assessment : Through study completion, up to 6.5 years
Name of the outcome measure(*) : Respiratory infection rate
Description of the outcome measure : Respiratory infection rate in first year of life during supplementation
Type of the outcome measure : Secondary
Time point(s) of assessment : 1 year
Name of the outcome measure(*) : Measurement of Safety parameters
Description of the outcome measure : Adverse Events and Serious Adverse Events will be captured until 30 days after the last administration of the food product.Local and systemic adverse effects will be elicited by direct questioning of the participant or parent. Systemic effects will be sought by questioning about any untoward symptoms or signs, and graded as mild, moderate, severe, life-threatening or death according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Type of the outcome measure : Secondary
Time point(s) of assessment : from Baseline until 30 days after end of supplementation
Name of the outcome measure(*) : Allergy
Description of the outcome measure : Participant's parents will be asked to complete questionnaires to obtain information about allergies every 12 months. Analyses will compare the B. infantis supplementation and placebo groups for the frequency of allergy and allergy sub-groups as defined form the yearly questionnaires.
Type of the outcome measure : Not specified
Time point(s) of assessment : Through study completion, up to 6.5 years
Name of the outcome measure(*) : Antibody response (IgG titres) to vaccines
Description of the outcome measure : Information about rotavirus and MMR vaccination will be collected from parents and antibody response (IgG titers) will be measured centrally.
Type of the outcome measure : Not specified
Time point(s) of assessment : at age 6 months (rotavirus) and at age 2 years (MMR)
Name of the outcome measure(*) : Alterations of the gut microbiome or blood metabolome
Description of the outcome measure : Exploratory analyses will examine the associations between B. infantis supplementation and mouth and stool organisms (microbiome), and blood markers such as the metabolome.
Type of the outcome measure : Not specified
Time point(s) of assessment : from baseline to age 12 months
Name of the outcome measure(*) : Stool pH
Description of the outcome measure : Stool pH levels will be compared between B. infantis supplementation and placebo groups in a subset of children
Type of the outcome measure : Not specified
Time point(s) of assessment : at age 6 months
Name of the outcome measure(*) : Stool calprotectin
Description of the outcome measure : Stool calprotectin levels will be compared between B. infantis supplementation and placebo groups in a subset of children
Type of the outcome measure : Not specified
Time point(s) of assessment : at age 6 months
Additional information about the Project : Are healthy volunteers permitted to participate in the clinical study?: TrueIs eligibility based on gender (not on sex)?: Additional information about gender eligibility criteria:
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not applicable
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Care provider, Investigator, Outcomes assessor
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

Supplementation with B. infantis to mitigate Type 1 Diabetes Autoimmunity

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