Multi-Center Registry for ME/CFS (MECFS-R)

Multi-Center Registry for ME/CFS, Including ME/CFS Following Epstein-Barr Virus-Associated Infectious Mononucleosis (EBV-IM) or Coronavirus Disease 2019 (Covid-19)

The ME/CFS study (MECFS-R) aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for ME/CFS at any age in Germany, which can be used for future clinical trials.

Study Overview

• Status: Recruiting
• Conditions: ME/CFS; CFS/ME; ME/CFS Following EBV-associated Infectious Mononucleosis; ME/CFS Following COVID-19

Detailed Description

ME/CFS (ICD-10 G93.3) is a multisystem chronic disease that can lead to severe disability. Pre-pandemic prevalence was estimated at approximately 0.3% worldwide, and increasing prevalence is observed due to ME/CFS in the context of long-term sequelae of coronavirus diseases 2019 (COVID-19). In Germany, the number of affected people in Germany was estimated as approximately 350.000-400.000 in 2018/2019 and almost 500.000 in 2021. ME/CFS can manifest at any age, with peak prevalence in adolescents and young adults. Common triggers include COVID, influenza, and Epstein-Barr virus-associated infectious mononucleosis (EBV-IM). Non-infectious triggers are known as well. Autoimmunity and dysfunction of the autonomic nervous system (ANS) were suggested as possible pathomechanisms. Core symptoms include fatigue, post-exertional malaise (PEM), and unrefreshing sleep. Additional symptoms comprise cognitive deficits ("brain fog"), orthostatic intolerance, neuroendocrine, and immunological symptoms. ME/CFS is diagnosed according to clinical criteria (mostly criteria by the Institute of Medicine (IOM) or Canadian Consensus Criteria) and by appropriate differential diagnostics to exclude other disorders with similar symptoms. So far, no biomarker or specific therapy is available. Therapeutic approaches are holistic and aim at the palliation of symptoms as well as psychosocial support. Self-management with pacing is recommended. Knowledge of ME/CFS among healthcare providers is still scarce, and many patients do not receive adequate care.

With this web-based, German-wide registry, the investigators aim at deep phenotyping of the disease, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. Patients are also invited to contribute biosamples for future translational research.

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Uta Behrends, Prof. Dr. med.; Phone Number: +4989 30682632; Email: uta.behrends@tum.de
• Study Contact Backup: Name: Daniela Schindler, Dr.; Phone Number: +4989 41406995

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80804
      • Recruiting
      • MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
      • Contact: Uta Behrends, Prof.; Phone Number: +89 30682632; Email: register.mcfc@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with ME/CFS

Description

Inclusion Criteria:

• ME/CFS diagnosis (ICD-10 G93.3) based on internationally established criteria
• Informed consent by patients and/or guardian(s)

Exclusion Criteria:

• No ME/CFS (ICD-10 G93.3)
• No informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenotyping ME/CFS: Medical History	Routine assessment of the medical history, such as current and previous medication, vaccinations, comorbidities, and more, to achieve a profound ME/CFS phenotype.	30 years
Assessment of routine physical examination findings	Routine physical examination to achieve a profound and detailed ME/CFS phenotype.	30 years
Number of participants with abnormal laboratory tests results	Measurement of a routine set of laboratory parameters including blood tests (cell count[cell/µl], C-reactive protein [mg/dl], immunoglobulins A/M/G [md/dl], antinuclear antibodies [titer], etc.) and urine/stool analysis (e.g. calprotectin [mg/kg], positive hemoglobin in urine test stripe) to achieve a profound ME/CFS phenotype.	30 years
Number of participants with abnormal technical exam results	Technical exams (e.g. restrictive and obstructive pattern in pulmonary function tests, conduction in electrocardiography, ultrasound imaging, magnetic resonance imaging, etc.) will be performed as indicated to achieve a profound and detailed ME/CFS phenotype.	30 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Patient Journeys	Patients' journeys will be analyzed regarding the specialization of involved physicians visited, time to diagnosis, and time to treatment.	30 years
Definition of Sub-cohorts	Using routine data, sub-cohorts will be identified.	30 years
Prevalence of Comorbidities	Prevalence of comorbidities of patients with ME/CFS will be analyzed.	30 years
Identification of Candidate Prognostic Markers	Correlation of routine clinical data (e.g., medical history, routine laboratory, and physical examination) with clinical outcome (e.g., health-related quality of life, disease severity, and social participation).	30 years

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Uta Behrends, Prof. Dr. med., MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): May 31, 2052
• Study Completion (Estimated): May 31, 2052

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; EBV; Chronic fatigue syndrome; Myalgic encephalomyelitis; Epstein-Barr virus; ME/CFS; CFS/ME; Post-COVID-19 condition; COVID-10
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Leukocyte Disorders; Hematologic Diseases; DNA Virus Infections; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Epstein-Barr Virus Infections; Herpesviridae Infections; COVID-19; Fatigue Syndrome, Chronic; Infections; Communicable Diseases; Infectious Mononucleosis
• Other Study ID Numbers: MECFS-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No