NCT06005246

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2019Jan 2029

Study Start

First participant enrolled

January 22, 2019

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Expected
Last Updated

August 22, 2023

Status Verified

July 1, 2023

Enrollment Period

4.9 years

First QC Date

July 24, 2023

Last Update Submit

August 16, 2023

Conditions

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

Keywords

ME/CFSCFS/MESEIDmyalgic encephalomyelitischronic fatigue syndromeinfectious mononucleosissystemic exertion intolerance diseaseEpstein-Barr viruspost-COVID-19-syndromepost-COVID-19 conditionlong COVIDpost-acute sequelae of COVID-19

Outcome Measures

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)

    5 years

Secondary Outcomes (2)

  • Risk factors

    5 years

  • Biomarkers

    5 years

Eligibility Criteria

AgeUp to 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The number of study participants will not be limited.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Related Publications (1)

  • 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.

    PMID: 38304441BACKGROUND

Related Links

MeSH Terms

Conditions

Fatigue Syndrome, ChronicInfectious MononucleosisEpstein-Barr Virus InfectionsPost-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesTumor Virus InfectionsCOVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious Disorders

Study Officials

  • Uta Behrends, Prof. Dr.

    München Klinik Schwabing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Uta Behrends, Prof. Dr.

CONTACT

+49 89 4140 2632uta.behrends@mri.tum.de

Kirstin Mittelstraß, Dr.

CONTACT

+49 89 4140 3046kirstin.mittelstrass@mri.tum.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 22, 2023

Study Start

January 22, 2019

Primary Completion

January 1, 2024

Study Completion (Estimated)

January 1, 2029

Last Updated

August 22, 2023

Record last verified: 2023-07

Locations

DE(1)