ME/CFS and post-COVID Chronic fatigue syndrome and long covid
Conditions
Interventions
nvt
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients: For eligibility, patients must meet the following criteria: - Age of 8-19 years old; - Able to speak, read, understand, and write Dutch; - ME/CFS patients: A (suspected) diagnosis of ME/CFS according to the CCC and severely fatigued, as indicated by a fatigue severity score of >= 21 on the Checklist Individual Strength-4 (CIS-4) questionnaire. - Post-COVID patients: a (suspected) diagnosis of post-COVID according to the WHO definition. Patients should express that their symptoms started after acute COVID-19 infection. CCC will be monitored. Inclusion criteria for healthy controls: For eligibility, healthy controls must meet the following criteria: - Age of 8-19 years old; - Able to speak, read, understand, and write Dutch; - No ME/CFS diagnosis according to the CDC, CCC and ICC; - No post-COVID condition or other manifestation of persistent fatigue and/or pain; - Not severely fatigued, as indicated by a fatigue severity score of <21 on the CIS-4 questionnaire.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participation in this cohort: Having any concomitant diagnoses that may explain the fatigue (also including predominated psychiatric comorbidity such as major depression disorder, generalised anxiety disorder, presence of suicidal risk, etc.). Being on therapeutic anticoagulant treatment (with an exception for acetylsalicylic acid, dipyridamole) or having a high risk of bleeding due to a coagulation disorder. Having cognitive impairment (with an estimated IQ of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For our primary endpoint we will clinically (questionnaires and physiological tests; e.g. fatigue) and biologically characterise patients and controls. For biological characterisation we will focus on determining blood proteome (with multiplex assays we will determine ~200 proteins) and blood metabolome (untargeted direct-infusion high-resolution mass spectrometry, >1800 metabolites, on blood and isolated immune cells followed by validation through targeted LC-MS/MS based metabolomics, depending on the initial findings) to identify factors that can discriminate paediatric ME/CFS and post-COVID from healthy controls or identify subgroups within the patient group. For clinical characterisation we will focus on: • The ME/CFS criteria. Several criteria exist to diagnose children with ME/CFS. These criteria differ in stringency. To participate in this study, all patients must meet the Canadian Consensus Criteria. To characterise patients further, we will check whether patients also meet the CCC and ICC criteria for ME/CFS. To see the differences between the three criteria, we refer to the table below. Doctor reports from standard care and DSQ questionnaires will be used to check whether patients meet all criteria. • Self-reported data at inclusion (demographic, behavioural, symptoms, clinical, and fatigue/pain) at inclusion, repeated 6 and 12 months after inclusion. For more information, see METC protocol 24/217. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will determine: • Hair cortisol • Oral microbiota composition • Immune cell transcriptome: RNA sequencing • Dynamic change in metabolism (fluxomics) • Derangements in mitochondrial functions in immune cells (e.g. mitophagy, mitochondrial membrane potential, fission and fusion, and superoxide production • Rest material of biologicals will be stored in a biobank for 15 years. This biobank is the central biobank of the UMCU and is located in the Wilhelmina Children's Hospital. This biobank will be created to facilitate (future) research on ME/CFS, post-COVID and other immune diseases. Biomaterials can be requested by our consortium members for research purposes if participants gave informed consent for research related to chronic fatigue and other immune or metabolic diseases. • Other study parameters/endpoints: Researchers from the national effort (the Netherlands ME/CFS Cohort and Biobank, NMCB, consortium and Post-COVID Network Netherlands, PCNN) funded by ZonMw may request data from our cohort for their research purposes or to collaborate with us. These specific research questions remain to be determined and will also depend on the research now done in adults. | — |
Countries
Netherlands
Contacts
Public ContactH. L. D. M Willemen
Universitair Medisch Centrum Utrecht
Outcome results
None listed