Protocol for a multicentre cross-sectional, longitudinal ambulatory clinical trial in rheumatoid arthritis and Parkinson's disease patients analysing the relation between the gut microbiome, fasting and immune status in Germany (ExpoBiome).
Clinical trials; IMMUNOLOGY; MICROBIOLOGY; NUTRITION & DIETETICS; Parkinson-s disease; Rheumatology; Humans; Cross-Sectional Studies; Longitudinal Studies; Fasting; Germany; Ethics Committees, Research; Multicenter Studies as Topic; Gastrointestinal Microbiome; Parkinson Disease/therapy; Arthritis, Rheumatoid/therapy; Arthritis, Rheumatoid; Parkinson Disease; Medicine (all); General Medicine
Résumé :
[en] [en] INTRODUCTION: Chronic inflammatory diseases like rheumatoid arthritis (RA) and neurodegenerative disorders like Parkinson's disease (PD) have recently been associated with a decreased diversity in the gut microbiome, emerging as key driver of various diseases. The specific interactions between gut-borne microorganisms and host pathophysiology remain largely unclear. The microbiome can be modulated by interventions comprising nutrition.The aim of our clinical study is to (1) examine effects of prolonged fasting (PF) and time-restricted eating (TRE) on the outcome parameters and the immunophenotypes of RA and PD with (2) special consideration of microbial taxa and molecules associated with changes expected in (1), and (3) identify factors impacting the disease course and treatment by in-depth screening of microorganisms and molecules in personalised HuMiX gut-on-chip models, to identify novel targets for anti-inflammatory therapy.
METHODS AND ANALYSIS: This trial is an open-label, multicentre, controlled clinical trial consisting of a cross-sectional and a longitudinal study. A total of 180 patients is recruited. For the cross-sectional study, 60 patients with PD, 60 patients with RA and 60 healthy controls are recruited at two different, specialised clinical sites. For the longitudinal part, 30 patients with PD and 30 patients with RA undergo 5-7 days of PF followed by TRE (16:8) for a period of 12 months. One baseline visit takes place before the PF intervention and 10 follow-up visits will follow over a period of 12 months (April 2021 to November 2023).
ETHICS AND DISSEMINATION: Ethical approval was obtained to plan and conduct the trial from the institutional review board of the Charité-Universitätsmedizin Berlin (EA1/204/19), the ethics committee of the state medical association (Landesärztekammer) of Hessen (2021-2230-zvBO) and the Ethics Review Panel (ERP) of the University of Luxembourg (ERP 21-001 A ExpoBiome). The results of this study will be disseminated through peer-reviewed publications, scientific presentations and social media.
TRIAL REGISTRATION NUMBER: NCT04847011.
Disciplines :
Sciences du vivant: Multidisciplinaire, généralités & autres
Auteur, co-auteur :
HANSEN, Bérénice ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Medical Translational Research
LACZNY, Cedric Christian ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Systems Ecology
AHO, Velma ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine > Systems Ecology > Team Paul WILMES
Frachet-Bour, Audrey; Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
Habier, Janine; Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
OSTASZEWSKI, Marek ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Bioinformatics Core
Michalsen, Andreas; Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany ; Department of Internal and Integrative Medicine, Immanuel Hospital Berlin-Wannsee Branch, Berlin, Germany
Hanslian, Etienne; Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany ; Department of Internal and Integrative Medicine, Immanuel Hospital Berlin-Wannsee Branch, Berlin, Germany
Koppold, Daniela A; Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany ; Department of Internal and Integrative Medicine, Immanuel Hospital Berlin-Wannsee Branch, Berlin, Germany
Hartmann, Anika M ; Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany ; Department of Dermatology, Venereology and Allergology, Charité Universitätsmedizin Berlin, Berlin, Germany
Steckhan, Nico; Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany ; Digital Health-Connected Healthcare, Hasso Plattner Institute, University of Potsdam, Potsdam, Germany
Mollenhauer, Brit; Neurosurgery, University Medical Center Göttingen, Gottingen, Germany ; Movement disorders and Parkinson's Disease, Paracelsus-Kliniken Deutschland GmbH, Osnabruck, Germany
Schade, Sebastian ; Neurosurgery, University Medical Center Göttingen, Gottingen, Germany ; Movement disorders and Parkinson's Disease, Paracelsus-Kliniken Deutschland GmbH, Osnabruck, Germany
RUMP, Kirsten ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Bioinformatics Core
SCHNEIDER, Jochen ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Medical Translational Research ; Department of Internal Medicine and Psychiatry, Saarland University Hospital and Saarland University Faculty of Medicine, Homburg, Germany
WILMES, Paul ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Systems Ecology
Protocol for a multicentre cross-sectional, longitudinal ambulatory clinical trial in rheumatoid arthritis and Parkinson's disease patients analysing the relation between the gut microbiome, fasting and immune status in Germany (ExpoBiome).
H2020 - 863664 - ExpoBiome - Deciphering the impact of exposures from the gut microbiome-derived molecular complex in human health and disease
Projet FnR :
FNR11823097 - Microbiomes In One Health, 2017 (01/09/2018-28/02/2025) - Paul Wilmes
Organisme subsidiant :
H2020 European Research Council Union Européenne
Subventionnement (détails) :
This project has received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation program (grant agreement number 863664). This work was supported by the Luxembourg National Research Fund (FNR) under grant PRIDE/11823097.
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