Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
NCT ID: NCT04769037
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1149 participants
INTERVENTIONAL
2021-04-22
2027-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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B. infantis
Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day
B. infantis
Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day
Placebo
Lactose identical in appearance and taste to the active supplement
Placebo
Lactose identical in appearance and taste to the active supplement
Interventions
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B. infantis
Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day
Placebo
Lactose identical in appearance and taste to the active supplement
Eligibility Criteria
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Inclusion Criteria
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
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
7 Days
6 Weeks
ALL
Yes
Sponsors
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Technical University of Munich
OTHER
Kinderkrankenhaus auf der Bult
OTHER
University Hospital Carl Gustav Carus
OTHER
Skane University Hospital
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Medical University of Warsaw
OTHER
Cambridge Biomedical Campus, Cambridge, UK
UNKNOWN
Royal Victoria Infirmary, Newcastle upon Tyne, UK
UNKNOWN
Helmholtz Zentrum München
INDUSTRY
Responsible Party
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Anette-Gabriele Ziegler
Director - Institute of Diabetes Research
Locations
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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
Malmo, , Sweden
University Department of Paediatrics, Cambridge Biomedical Campus
Cambridge, , United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne
Newcastle, , United Kingdom
Countries
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References
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Ziegler AG, Arnolds S, Kolln A, Achenbach P, Berner R, Bonifacio E, Casteels K, Elding Larsson H, Gundert M, Hasford J, Kordonouri O, Lundgren M, Oltarzewski M, Pekalski ML, Pfirrmann M, Snape MD, Szypowska A, Todd JA; GPPAD STUDY GROUP. Supplementation with Bifidobacterium longum subspecies infantis EVC001 for mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A randomised controlled trial protocol. BMJ Open. 2021 Nov 9;11(11):e052449. doi: 10.1136/bmjopen-2021-052449.
Related Links
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Related Info
Other Identifiers
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GPPAD-04
Identifier Type: -
Identifier Source: org_study_id