Munich ME/CFS Cohort Study (MUC-CFS)
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| ClinicalTrials.gov Identifier: NCT06005246 |
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Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | July 24, 2023 | ||||||||
| First Posted Date | August 22, 2023 | ||||||||
| Last Update Posted Date | August 22, 2023 | ||||||||
| Actual Study Start Date | January 22, 2019 | ||||||||
| Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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)
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Munich ME/CFS Cohort Study | ||||||||
| Official Title | Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS) | ||||||||
| Brief 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. | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The number of study participants will not be limited. | ||||||||
| Condition | Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3) | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2029 | ||||||||
| Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
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. |
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| Sex/Gender |
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| Ages | up to 25 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Germany | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT06005246 | ||||||||
| Other Study ID Numbers | MUC-CFS | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Technical University of Munich | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Technical University of Munich | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Technical University of Munich | ||||||||
| Verification Date | July 2023 | ||||||||