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)
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-bo...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e071380.full |
| _version_ | 1797738191442149376 |
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| author | Brit Mollenhauer Anika M Hartmann Nico Steckhan Jochen G Schneider Andreas Michalsen Etienne Hanslian Bérénice Hansen Cédric C Laczny Velma T E Aho Audrey Frachet-Bour Janine Habier Marek Ostaszewski Daniela A Koppold Sebastian Schade Kirsten Roomp Paul Wilmes |
| author_facet | Brit Mollenhauer Anika M Hartmann Nico Steckhan Jochen G Schneider Andreas Michalsen Etienne Hanslian Bérénice Hansen Cédric C Laczny Velma T E Aho Audrey Frachet-Bour Janine Habier Marek Ostaszewski Daniela A Koppold Sebastian Schade Kirsten Roomp Paul Wilmes |
| author_sort | Brit Mollenhauer |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T13:39:26Z |
| format | Article |
| id | doaj.art-7e14b9bf39184d26a4fbc467392086f2 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T13:39:26Z |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-7e14b9bf39184d26a4fbc467392086f22023-08-23T21:20:07ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2022-071380Protocol 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)Brit Mollenhauer0Anika M Hartmann1Nico Steckhan2Jochen G Schneider3Andreas Michalsen4Etienne Hanslian5Bérénice Hansen6Cédric C Laczny7Velma T E Aho8Audrey Frachet-Bour9Janine Habier10Marek Ostaszewski11Daniela A Koppold12Sebastian Schade13Kirsten Roomp14Paul Wilmes15Movement disorders and Parkinson’s Disease, Paracelsus-Kliniken Deutschland GmbH, Osnabruck, GermanyInstitute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, GermanyInstitute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, GermanyLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgInstitute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, GermanyInstitute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, GermanyLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgInstitute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, GermanyNeurosurgery, University Medical Center Göttingen, Gottingen, GermanyLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgLuxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, LuxembourgIntroduction 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.https://bmjopen.bmj.com/content/13/8/e071380.full |
| spellingShingle | Brit Mollenhauer Anika M Hartmann Nico Steckhan Jochen G Schneider Andreas Michalsen Etienne Hanslian Bérénice Hansen Cédric C Laczny Velma T E Aho Audrey Frachet-Bour Janine Habier Marek Ostaszewski Daniela A Koppold Sebastian Schade Kirsten Roomp Paul Wilmes 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/8/e071380.full |
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