The German Multicenter Registry for ME/CFS (MECFS-R)

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating multi-systemic disease characterized by a complex, incompletely understood etiology. To facilitate future clinical and translational research, a multicenter German ME/CFS registry was established to collect comprehensive, longitudinal, clinical, epidemiological, and laboratory data from adults, adolescents, and children in a web-based multilayer-secured database. Here, we present the research protocol and first results of a pilot cohort of 174 ME/CFS patients diagnosed at two specialized tertiary fatigue centers, including 130 (74.7%) adults (mean age 38.4; SD 12.6) and 43 (25.3%) pediatric patients (mean age 15.5; SD 4.2). A viral trigger was identified in 160/174 (92.0%) cases, with SARS-CoV-2 in almost half of them. Patients exhibited severe functional and social impairment, as reflected by a median Bell Score of 30.0 (IQR 30.0 to 40.0) and a poor health-related quality of life assessed with the Short form-36 health survey, resulting in a mean score of 40.4 (SD 20.6) for physical function and 59.1 (SD 18.8) for mental health. The MECFS-R provides important clinical information on ME/CFS to research and healthcare institutions and, together with a multicenter ME/CFS biobank, will pave the way for research projects addressing the pathogenesis, diagnostic markers, and treatment options. Trial registration: ClinicalTrials.gov [NCT05778006][1]. ### Competing Interest Statement U.B. received research grants from the Federal Ministry of Education and Research (BMBF), the BMG, the Bavarian State Ministry of Health and Care (StMGP), the Bavarian State Ministry of Science and the Arts (StMWK), the German Center for Infection Research (DZIF), the People for Children (Menschen fuer Kinder) foundation, the WZS, the Lost Voices foundation (LVS), the Siemens Caring hands foundation, and the ME/CFS research foundation (ME/CFS RF). C.S. was consulting Roche, Celltrend, and Bayer; she received support for clinical trials by Bayer, Fresenius, and Miltenyi, honoraria for lectures by Fresenius, AstraZeneca, BMS, Roche, Bayer, and Novartis, and research grants from the German Research Association (DFG), the BMBF, the BMG, the WZS, the LVS, and the ME/CFS RF. The authors declare no conflict of interest. The funders of individual researchers had no role in the design of the study, the collection, analyses, and interpretation of data, the writing of the manuscript, or the decision to publish results. ### Funding Statement The MECFS-R and biobank was funded by the Menschen fuer Kinder e:V., the Federal Ministry of Health (BMG) (project 01EJ2204) and the Weidenhammer-Zoebele foundation. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Ethics Committee of the Technical University of Munich Medical Center (MRI TUM), Germany (116/21 S) and by the Ethics Committee of Charite Universitaetsmedizin Berlin (EA/006/22). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data presented in this study are available from the corresponding author, upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05778006&atom=%2Fmedrxiv%2Fearly%2F2024%2F04%2F26%2F2024.04.25.24306335.atom