Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)MUC-CFSNCT06005246
Munich ME/CFS Cohort Study
An observational study of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3), run by Technical University of Munich at 1 site in Germany.
Trial summary
The Munich cohort study MUC-CFS aims at the characterization and long-term follow-up of myalgic encephalitis/chronic fatigue syndrome (ME/CFS) in young people aged up to 25 years, as well as at the identification of pathomechanisms, biomarkers, and targets for future treatment approaches. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2019to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- Child, Adult
Study population: The number of study participants will not be limited.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
MRI Chronic Fatigue Center for Young People (MCFC), Children's hospital, Technical University of Munich (TUM) and Munic Municipal Hospital (MüK)
Munich, Bavaria, 80804
Uta Behrends, Prof. Dr., uta.behrends@mri.tum.de
Kirstin Mittelstraß, Dr., kirstin.mittelstrass@mri.tum.de
About this study
Official title: Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS)
The Munich cohort study MUC-CFS aims at the characterization and long-term follow-up of myalgic encephalitis/chronic fatigue syndrome (ME/CFS) in young people aged up to 25 years, as well as at the identification of pathomechanisms, biomarkers, and targets for future treatment approaches.
Read the detailed description
ME/CFS is a complex, chronic neurological disorder with an estimated pre-pandemic prevalence of about 0.3%, affecting more people than multiple sclerosis (MS) worldwide. The number of cases was reported to increase due to long-term sequelae of COVID-19 (post-COVID condition). ME/CFS mainly affects young females aged 15-40 years but can occur in males and children. 25% are mildly, 50% moderately, and 25% severely affected.
Patients with ME/CFS suffer from fatigue, exertion intolerance with post-exertional malaise (PEM), cognitive impairment, pain, sleep disturbances, autonomic, and neuroendocrine manifestations, and flu-like symptoms. ME/CFS accounts for many cases of long-term school or work absences, with subsequent high social and economic burdens. The health-related quality of life is lower than in other severe chronic diseases.
Most ME/CFS cases are triggered by an infection-like event (so-called post-infection ME/CFS). Prominent triggers of ME/CFS include Epstein-Barr virus-associated infectious mononucleosis (EBV-IM) and coronavirus disease 2019 (COVID-19). Moreover, cases following other infectious diseases (e.g., other COVID, Influenza, Dengue fever, Ebola) are well documented.
Possible mechanisms contributing to the pathogenesis of ME/CFS include reactivation of latent viral infections, chronic inflammation, and autoimmunity, resulting in metabolic, neurological, and vascular dysregulation. However, no biomarker or causative treatment for ME/CFS has been established yet.
ME/CFS (ICD10 G93.3) affords appropriate differential diagnostics and is defined by clinical criteria. The criteria most commonly used are the criteria for "systemic exertion intolerance disease (SEID) defined by the former Institute of Medicine (IOM) and the Canadian Consensus Criteria (CCC). Adapted pediatric criteria have been suggested by the groups of P.C. Rowe and L.A. Jason in the US.
ME/CFS treatment includes comprehensive patient education regarding self-management strategies (e.g., pacing, relaxation strategies, sleep hygiene) as well as pharmaceutical and non-pharmaceutical approaches to palliate symptoms such as pain, sleep disorder, or orthostatic intolerance. Appropriate psychosocial support for patients and their families is essential. Follow-up studies indicated a better prognosis in children compared to adults.
The MUC-CFS cohort study is recruiting patients from the MRI Chronic Fatigue Center for Young People (MCFC) at the Technical University of Munich (TUM) and the Munich Municipal Hospital (MüK) in Munich, Germany. The MCFC closely cooperates with the Charité Fatigue Center (CFC) in Berlin, Germany, and has long-standing expertise in ME/CFS care and research.
The MUC-CFS cohort study aims to collect comprehensive clinical data regarding medical history, clinical and laboratory phenotypes, the trajectory of individual diseases, health-related quality of life, education, and social participation. Clinical data are derived from complex initial investigations at in- or out-patient visits as well as from following telephone calls and from various questionnaires. Biosampling (blood, urine, and/or mouthwashes) takes place at any personal visit for later cell-analytical, molecular, and/or biochemical analyses by our study group.
- Keywords
- ME/CFS, CFS/ME, SEID, myalgic encephalomyelitis, chronic fatigue syndrome, infectious mononucleosis, systemic exertion intolerance disease, Epstein-Barr virus, post-COVID-19-syndrome, post-COVID-19 condition, long COVID, post-acute sequelae of COVID-19
- Medical subject headings
- Fatigue Syndrome, Chronic, Infectious Mononucleosis, Epstein-Barr Virus Infections, Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Extensive Phenotyping of ME/CFS Patients
Extensive phenotyping of children, adolescent, and young adult patients with post-infectious ME/CFS (e.g., age, gender, medical history, daily function, health-related quality of life, severity and frequency of symptoms, disease trajectory over time)
Measured: 5 years
Secondary outcomes (2)
Risk factors
Identification of risk factors for protracted courses without (partial) remission (e.g., age at symptom onset, sex, sociodemographic variables, medical history, medication, daily function at symptom onset, severity and frequency of symptoms at symptom onset, laboratory values, EBV serology, EBV DNA load).
Measured: 5 years
Biomarkers
Identification of diagnostic biomarkers, i.e., a single and/or a combination of which, indicative of post-infectious ME/CFS (e.g., inflammatory markers, autoantibodies, EBV serology, EBV DNA load).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start22 Jan 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz Zentrum München, German Cancer Research Center, Charité University Hospital, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Uta Behrends, Prof. Dr., Principal investigator, München Klinik Schwabing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005246
- Sponsor's protocol ID
- MUC-CFS
- Acronym
- MUC-CFS
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pricoco R, Meidel P, Hofberger T, Zietemann H, Mueller Y, Wiehler K, Michel K, Paulick J, Leone A, Haegele M, Mayer-Huber S, Gerrer K, Mittelstrass K, Scheibenbogen C, Renz-Polster H, Mihatsch L, Behrends U. One-year follow-up of young people with ME/CFS following infectious mononucleosis by Epstein-Barr virus. Front Pediatr. 2024 Jan 18;11:1266738. doi: 10.3389/fped.2023.1266738. eCollection 2023.
PubMed 38304441
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS)
- ClinicalTrials.gov ID
- NCT06005246
- Acronym / sponsor ID
- MUC-CFS / MUC-CFS
- Keywords
- ME/CFS, CFS/ME, SEID, myalgic encephalomyelitis, chronic fatigue syndrome, infectious mononucleosis, systemic exertion intolerance disease, Epstein-Barr virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Helmholtz Zentrum München, German Cancer Research Center, Charité University Hospital, Berlin, Germany
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Munich cohort study MUC-CFS aims at the characterization and long-term follow-up of myalgic encephalitis/chronic fatigue syndrome (ME/CFS) in young people aged up to 25 years, as well as at the identification of pathomechanisms, biomarkers, and targets for future treatment approaches.
Detailed description
ME/CFS is a complex, chronic neurological disorder with an estimated pre-pandemic prevalence of about 0.3%, affecting more people than multiple sclerosis (MS) worldwide. The number of cases was reported to increase due to long-term sequelae of COVID-19 (post-COVID condition). ME/CFS mainly affects young females aged 15-40 years but can occur in males and children. 25% are mildly, 50% moderately, and 25% severely affected.
Patients with ME/CFS suffer from fatigue, exertion intolerance with post-exertional malaise (PEM), cognitive impairment, pain, sleep disturbances, autonomic, and neuroendocrine manifestations, and flu-like symptoms. ME/CFS accounts for many cases of long-term school or work absences, with subsequent high social and economic burdens. The health-related quality of life is lower than in other severe chronic diseases.
Most ME/CFS cases are triggered by an infection-like event (so-called post-infection ME/CFS). Prominent triggers of ME/CFS include Epstein-Barr virus-associated infectious mononucleosis (EBV-IM) and coronavirus disease 2019 (COVID-19). Moreover, cases following other infectious diseases (e.g., other COVID, Influenza, Dengue fever, Ebola) are well documented.
Possible mechanisms contributing to the pathogenesis of ME/CFS include reactivation of latent viral infections, chronic inflammation, and autoimmunity, resulting in metabolic, neurological, and vascular dysregulation. However, no biomarker or causative treatment for ME/CFS has been established yet.
ME/CFS (ICD10 G93.3) affords appropriate differential diagnostics and is defined by clinical criteria. The criteria most commonly used are the criteria for "systemic exertion intolerance disease (SEID) defined by the former Institute of Medicine (IOM) and the Canadian Consensus Criteria (CCC). Adapted pediatric criteria have been suggested by the groups of P.C. Rowe and L.A. Jason in the US.
ME/CFS treatment includes comprehensive patient education regarding self-management strategies (e.g., pacing, relaxation strategies, sleep hygiene) as well as pharmaceutical and non-pharmaceutical approaches to palliate symptoms such as pain, sleep disorder, or orthostatic intolerance. Appropriate psychosocial support for patients and their families is essential. Follow-up studies indicated a better prognosis in children compared to adults.
The MUC-CFS cohort study is recruiting patients from the MRI Chronic Fatigue Center for Young People (MCFC) at the Technical University of Munich (TUM) and the Munich Municipal Hospital (MüK) in Munich, Germany. The MCFC closely cooperates with the Charité Fatigue Center (CFC) in Berlin, Germany, and has long-standing expertise in ME/CFS care and research.
The MUC-CFS cohort study aims to collect comprehensive clinical data regarding medical history, clinical and laboratory phenotypes, the trajectory of individual diseases, health-related quality of life, education, and social participation. Clinical data are derived from complex initial investigations at in- or out-patient visits as well as from following telephone calls and from various questionnaires. Biosampling (blood, urine, and/or mouthwashes) takes place at any personal visit for later cell-analytical, molecular, and/or biochemical analyses by our study group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The number of study participants will not be limited.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extensive Phenotyping of ME/CFS Patients
Time frame: 5 years
Extensive phenotyping of children, adolescent, and young adult patients with post-infectious ME/CFS (e.g., age, gender, medical history, daily function, health-related quality of life, severity and frequency of symptoms, disease trajectory over time)
2 secondary outcomes
Risk factors
Time frame: 5 years
Biomarkers
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 38304441Pricoco R, Meidel P, Hofberger T, Zietemann H, Mueller Y, Wiehler K, Michel K, Paulick J, Leone A, Haegele M, Mayer-Huber S, Gerrer K, Mittelstrass K, Scheibenbogen C, Renz-Polster H, Mihatsch L, Behrends U. One-year follow-up of young people with ME/CFS following infectious mononucleosis by Epstein-Barr virus. Front Pediatr. 2024 Jan 18;11:1266738. doi: 10.3389/fped.2023.1266738. eCollection 2023.
Related trials for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)
Not yet recruiting
Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to Improve Fatigue, Pain, and Quality of Life by Targeting Mitochondrial Dysfunction and Autonomic Nervous System Impairment
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)
Active, not recruitingObservational study
A Prospective Study to Evaluate the Role of T-Cell Dysfunction in Patients Who Present Symptoms Associated With Long COVID, Lyme Disease and Myalic Encephalomyelitis / Chronic Fatigue Syndrome Using the Vira Immune Fluorospot T Cell Assay
Long COVID, PTLDs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uta Behrends, Prof. Dr. principal investigator
München Klinik Schwabing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3), run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uta Behrends, Prof. Dr. (+49 89 4140 2632, uta.behrends@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extensive Phenotyping of ME/CFS Patients (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.