ClinicalTrials.gg
RecruitingNCT06005246MUC-CFSUpdated Aug 22, 2023

Munich ME/CFS Cohort Study

An observational study in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3), sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged Up to 25 Years. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Technical University of Munich · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2019; still recruiting 7 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
Up to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Fatigue Syndrome, Chronic with a site in Germany — 8 open to participants now, 10 under way, none of them phase 3. Fatigue Syndrome, Chronic · Germany.

Started
2019
the only one that year
Observational
9 of 17
5 open now
Registered
11th of 17
by date
Lead sponsor
3 of 17
Technical University of Munich

Among the 17 studies in Fatigue Syndrome, Chronic with a site in Germany, this one is the only one that started in 2019, is one of 9 observational ones, and was the 11th registered.

Fatigue Syndrome, Chronic

263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.

Browse Fatigue Syndrome, Chronic studies →

Open to participants now

8 of the 17 studies in Fatigue Syndrome, Chronic with a site in Germany are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 43 Fatigue Syndrome, Chronic studies recruiting now, 18 (42%) set no upper age limit and 20 (47%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: Up to 25 Years · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Fatigue Syndrome, Chronic with a site in Germany, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)

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
04

Who can participate

Ages eligible
Up to 25 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The number of study participants will not be limited.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, /C, multiple sclerosis, systemic lupus erythematosus, Sjörgren's syndrome, , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 5 years

Secondary outcomes

  1. 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).

    Time frame: 5 years

  2. 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).

    Time frame: 5 years

07

Study locations

1 of 1 sites 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, Germany
    Recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Jan 2024, 60 months after the start.

Of 39 non-industry observational studies under Fatigue Syndrome, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 60 months is above that.

Counting every sponsor, half of 41 studies reached it within 44 months; a quarter within 25 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2023
First posted
Aug 22, 2023
StartActual
Jan 22, 2019
Primary completionEst.
Jan 2024
CompletionEst.
Jan 2029
Last update
Aug 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06005246
Collaborators
Helmholtz Munich, Munich, German Cancer Research Center, Charité University Hospital, Berlin, Germany
Responsible party
Sponsor
First posted
Aug 22, 2023
Start date
Jan 22, 2019
Primary completion
Jan 2024 (estimated)
Completion
Jan 2029 (estimated)
Last update
Aug 22, 2023

Study contacts

Uta Behrends, Prof. Dr.
Contact
uta.behrends@mri.tum.de
+49 89 4140 2632
Kirstin Mittelstraß, Dr.
Contact
kirstin.mittelstrass@mri.tum.de
+49 89 4140 3046
Uta Behrends, Prof. Dr.
principal investigator · München Klinik Schwabing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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