Clinical trial · Observational
Multi-Center Registry for ME/CFS
Multi-Center Registry for ME/CFS, Including ME/CFS Following Epstein-Barr Virus-Associated Infectious Mononucleosis (EBV-IM) or Coronavirus Disease 2019 (Covid-19)
NCT05778006CI-TRIAL-00084558MECFS-RrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CFS/ME | — | UNRESOLVED | — |
| ME/CFS | — | UNRESOLVED | — |
| ME/CFS Following COVID-19 | — | UNRESOLVED | — |
| ME/CFS Following EBV-associated Infectious Mononucleosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Phenotyping ME/CFS: Medical History
- timeFrame
- 30 years
- description
- Routine assessment of the medical history, such as current and previous medication, vaccinations, comorbidities, and more, to achieve a profound ME/CFS phenotype.
- measure
- Assessment of routine physical examination findings
- timeFrame
- 30 years
- description
- Routine physical examination to achieve a profound and detailed ME/CFS phenotype.
- measure
- Number of participants with abnormal laboratory tests results
- timeFrame
- 30 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHieber H, Pricoco R, Gerrer K, Heindrich C, Wiehler K, Mihatsch LL, Haegele M, Schindler D, Donath Q, Christa C, Grabbe A, Kircher A, Leone A, Mueller Y, Zietemann H, Freitag H, Sotzny F, Warlitz C, Stojanov S, Hattesohl DBR, Hausruckinger A, Mittelstrass K, Scheibenbogen C, Behrends U. The German Multicenter Registry for ME/CFS (MECFS-R). J Clin Med. 2024 May 28;13(11):3168. doi: 10.3390/jcm13113168. PMID 38892879