Supplementation with Bifidobacterium longum subspecies infantis EVC001 for mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A randomised controlled trial protocol

• Matthew D Snape,
• Melanie Gündert,
• Anette-Gabriele Ziegler,
• Peter Achenbach,
• Reinhard Berner,
• Kristina Casteels,
• Thomas Danne,
• Joerg Hasford,
• Olga Kordonouri,
• Karin Lange,
• Helena Elding Larsson,
• Markus Lundgren,
• Agnieszka Szypowska,
• John A Todd,
• Ezio Bonifacio,
• Nicole Zubizarreta,
• Christiane Winkler,
• Åke Lernmark,
• Daniel Agardh,
• Cigdem Gezginci,
• Claudia Ramminger,
• Marlon Scholz,
• Katharina Warncke,
• Carin Andrén Aronsson,
• Rasmus Bennet,
• Lina Fransson,
• Helena Elding Larsson,
• Zeliha Mestan,
• Caroline Nilsson,
• Anita Ramelius,
• Carina Törn,
• Sarah Hogg,
• Catherine Owen,
• Lidia Groele,
• Florian Haupt,
• Claudia Matzke,
• Robin Assfalg,
• Matthew Snape,
• Felix Reschke,
• Marcin L Pekalski,
• Andreas Weiss,
• Andrew Johnston,
• Manja Jolink,
• Loredana Marcovecchio,
• Mariusz Ołtarzewski,
• Stefanie Arnolds,
• Annika Kölln,
• Markus Pfirrmann,
• Corinna Barz,
• Karina Blasius,
• Nadine Friedl,
• Adriano Gomez-Bantel,
• Martin Heigermoser,
• Bianca Höfelschweiger,
• Nadine Klein,
• Ramona Lickert,
• Rebecca Niewöhner,
• Katharina Schütte-Borkovec,
• Mira Taulien,
• Lara Vogel,
• Franziska Voß,
• José Maria Zapardiel Gonzalo,
• Philipp Sifft,
• Heidi Kapfelsberger,
• Merve Vurucu,
• Katharina Sarcletti,
• Stefanie Jacobson,
• Yulia Grinin,
• John A. Todd,
• Anette-G. Ziegler,
• Marcin L. Pekalski,
• Anette G. Ziegler,
• Annre Rochtus,
• An Jacobs,
• Jasmin Paulus,
• Brontë Vrancken,
• Natalie Van den Driessche,
• Renka Van Heyste,
• Janne Houben,
• Veerle Vanhuyse,
• Sevina Dietz,
• Gita Gemulla,
• Manja Gottschalk-Schwarz,
• Sophie Heinke,
• Angela Hommel,
• Susann Kowal,
• Fabian Lander,
• Robert Morgenstern,
• Marc Weigelt,
• Sari Arabi,
• Raphael Hoffmann,
• Ruth Blechschmidt,
• Franziska Ehrlich,
• Anja Loff,
• Laura Galuschka,
• Ute Holtkamp,
• Nils Janzen,
• Sarah Landsberg,
• Erika Marquardt,
• Frank Roloff,
• Kerstin Semler,
• Thekla von dem Berge,
• Melanie Bunk,
• Simone Färber-Meisterjahn,
• Willi Grätz,
• Ines Greif,
• Melanie Herbst,
• Anna Hofelich,
• Benjamin Marcus,
• Annette Munzinger,
• Jasmin Ohli,
• Franziska Reinmüller,
• Tiziana Welzhofer,
• Sylwia Dybkowska,
• Katarzyna Dżygało,
• Dorota Owczarek,
• Katarzyna Popko,
• Agnieszka Skrobot,
• Anna Taczanowska,
• Beata Zduńczyk,
• Charlotte Brundin,
• Ida Jönsson,
• Sara Maroufkhani,
• Evelyn Tekum Amboh,
• Katarzyna Gajewska-Knapik,
• Elena Romero,
• Suzannah Twiss,
• Helen Gallon,
• Laura Gebbie,
• Fiona Jenkinson,
• Steven Pratt,
• Steve Robson,
• Claire Simmister,
• Evelyn Thomson,
• Eileen Walton

Affiliations

Matthew D Snape

11 Department of Paediatrics, University of Oxford, Oxford, UK

Melanie Gündert

1 Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany

Anette-Gabriele Ziegler

1 Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany

Peter Achenbach

1 Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany

Reinhard Berner

Department of Pediatrics, Technische Universität Dresden, Dresden, Germany

Kristina Casteels

4 Department of Paediatrics, University Hospitals Leuven, Leuven, Belgium

Thomas Danne

Diabeteszentrum für Kinder und Jugendliche, Kinderkrankenhaus auf der Bult, Hannover, Germany

Joerg Hasford

7 Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany

Olga Kordonouri

6 Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany

Karin Lange

8 Department of Medical Psychology, Hannover Medical School, Hannover, Germany

Helena Elding Larsson

9 Unit for Paediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Sweden

Markus Lundgren

Department of Paediatrics, Skåne University Hospital, Malmö, Sweden

Agnieszka Szypowska

Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland

John A Todd

14 Wellcome Centre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford, UK

Ezio Bonifacio

Center for Regenerative Therapies Dresden (CRTD), Faculty of Medicine, Technische Universität Dresden, Dresden, Germany

Nicole Zubizarreta

4 Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, New York, USA

Christiane Winkler

Åke Lernmark

Daniel Agardh

19 The Diabetes and Celiac Disease Unit, Department of Clinical Sciences, Lund University, Lund, Sweden

Cigdem Gezginci

Claudia Ramminger

Marlon Scholz

Katharina Warncke

Carin Andrén Aronsson

Rasmus Bennet

Lina Fransson

Helena Elding Larsson

Zeliha Mestan

Caroline Nilsson

Anita Ramelius

Carina Törn

Sarah Hogg

Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK

Catherine Owen

Department of Paediatric Endocrinology, Great North Children’s Hospital, Newcastle Upon Tyne, UK

Lidia Groele

Department of Paediatrics, The Children’s Clinical Hospital Józef Polikarp Brudziński, Warsaw, Poland

Florian Haupt

1Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Neuherberg, Germany

Claudia Matzke

1Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Neuherberg, Germany

Robin Assfalg

1Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Neuherberg, Germany

Matthew Snape

1Oxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, Oxfordshire, UK

Felix Reschke

1Klinik und Poliklinik für Kinder- und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

Marcin L Pekalski

1JDRF/Wellcome Trust Diabetes and Inflammation Laboratory, National Institute for Health Research Cambridge Biomedical Research Centre, Cambridge Institute for Medical Research, University of Cambridge, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK

Andreas Weiss

4IRBM Promidis, Pomezia, Italy

Andrew Johnston

2Department of Anaesthesia, Addenbrooke`s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK

Manja Jolink

1Helmholtz Zentrum München, Institut für Diabetesforschung, Munich, Germany

Loredana Marcovecchio

clinical research fellow

Mariusz Ołtarzewski

Institute of Mother and Child

Stefanie Arnolds

Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany

Annika Kölln

Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany

Markus Pfirrmann

Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany

Corinna Barz

Karina Blasius

Nadine Friedl

Adriano Gomez-Bantel

Martin Heigermoser

Bianca Höfelschweiger

Nadine Klein

Ramona Lickert

Rebecca Niewöhner

Katharina Schütte-Borkovec

Mira Taulien

Lara Vogel

Franziska Voß

José Maria Zapardiel Gonzalo

Philipp Sifft

Heidi Kapfelsberger

Merve Vurucu

Katharina Sarcletti

Stefanie Jacobson

Yulia Grinin

John A. Todd

Anette-G. Ziegler

Marcin L. Pekalski

Anette G. Ziegler

Annre Rochtus

An Jacobs

Jasmin Paulus

Brontë Vrancken

Natalie Van den Driessche

Renka Van Heyste

Janne Houben

Veerle Vanhuyse

Sevina Dietz

Gita Gemulla

Manja Gottschalk-Schwarz

Sophie Heinke

Angela Hommel

Susann Kowal

Fabian Lander

Robert Morgenstern

Marc Weigelt

Sari Arabi

Raphael Hoffmann

Ruth Blechschmidt

Franziska Ehrlich

Anja Loff

Laura Galuschka

Ute Holtkamp

Nils Janzen

Sarah Landsberg

Erika Marquardt

Frank Roloff

Kerstin Semler

Thekla von dem Berge

Melanie Bunk

Simone Färber-Meisterjahn

Willi Grätz

Ines Greif

Melanie Herbst

Anna Hofelich

Benjamin Marcus

Annette Munzinger

Jasmin Ohli

Franziska Reinmüller

Tiziana Welzhofer

Sylwia Dybkowska

Katarzyna Dżygało

Dorota Owczarek

Katarzyna Popko

Agnieszka Skrobot

Anna Taczanowska

Beata Zduńczyk

Charlotte Brundin

Ida Jönsson

Sara Maroufkhani

Evelyn Tekum Amboh

Katarzyna Gajewska-Knapik

Elena Romero

Suzannah Twiss

Helen Gallon

Laura Gebbie

Fiona Jenkinson

Steven Pratt

Steve Robson

Claire Simmister

Evelyn Thomson

Eileen Walton