Characterization of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in Young People
Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS)
This study looks at young people with chronic fatigue syndrome to see how it affects their lives and to find clues for better treatments in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06005246 on ClinicalTrials.gov |
What this trial studies
The Munich ME/CFS Cohort Study aims to characterize and conduct long-term follow-up of myalgic encephalitis/chronic fatigue syndrome (ME/CFS) in individuals aged up to 25 years. This observational study seeks to identify underlying mechanisms, potential biomarkers, and targets for future treatment approaches. Given the increasing prevalence of ME/CFS, particularly following infections like COVID-19, the study focuses on understanding the condition's impact on young patients and their quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are young individuals aged 0 to 25 who have a documented acute infectious disease at the onset of ME/CFS symptoms.
Not a fit: Patients with severe psychiatric illnesses, major organ failures, or other conditions that could explain their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of ME/CFS, ultimately improving the quality of life for affected patients.
How similar studies have performed: While there have been studies on ME/CFS, this cohort study's specific focus on young patients and the identification of biomarkers represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written consent of the patient (or legal guardian for patients aged \< 18 years). * Age 0 - 25 (including) * Documented or probable acute infectious disease at the onset of ME/CFS symptoms * Diagnosis of ME/CFS according to the IOM criteria, the CCC, the diagnostic worksheet published by P.C. Rowe et al. (2017), or the pediatric case definition published by L.A. Jason et al. (2006). Exclusion Criteria: • drug/medication abuse, major surgery within the last six months, presence of organ failure, post-stroke/craniocerebral trauma with cognitive deficits, post-intensive care syndrome, syphilis, Lyme disease, AIDS, hepatitis B/C, multiple sclerosis, systemic lupus erythematosus, Sjörgren's syndrome, malignancy, major depression or other severe psychiatric illness, primary sleep disorder, severe endocrine disease (e.g., hypopituitarism, adrenal insufficiency), and other conditions that might explain ME/CFS symptoms.
Where this trial is running
Munich, Bavaria
- MRI Chronic Fatigue Center for Young People (MCFC), Children's hospital, Technical University of Munich (TUM) and Munic Municipal Hospital (MüK) — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Uta Behrends, Prof. Dr. — München Klinik Schwabing
- Study coordinator: Uta Behrends, Prof. Dr.
- Email: uta.behrends@mri.tum.de
- Phone: +49 89 4140 2632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.