Clinical trial NCT06653712: Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers
Official title: Healthy Control Population für PAIS-ME/CFS: Studie Zur Evaluation möglicher Biomarker Und Untersuchungsmethoden für Die PAIS-ME/CFS-Diagnostik Bei Gesunden Probanden
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy Controls
Keywords: ME/CFS
Post-Covid
Biomarker
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Max-Planck Institut
name: University Hospital Erlangen
First posted: 2024-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls are recruited via public relations

Brief summary: Using the data from the HelP study, the underlying processes of the diseases ME/CFS and PAIS are to be researched and elucidated. The comparison of affected patients with healthy controls is intended to identify disease-specific patterns that could be related to the development or progression of the disease. The aim is to find a suitable biomarker for diagnostics and to develop therapeutic approaches.

Detailed description: The underlying pathomechanisms of the diseases PAIS and ME/CFS are to be investigated and elucidated in more detail. The aim is to establish a cohort of healthy controls at our MRI Chronic Fatigue Center (MCFC). Within this cohort, the measurement instruments used so far in ME/CFS diagnostics will be validated. In addition, data material from this pool should be used for the statistical evaluations of various case-control studies of our center and our cooperation partners in order to find and develop a suitable biomarker for diagnostics and therapeutic approaches for PAIS and ME/CFS.

Eligibility criteria: Inclusion Criteria:

* Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure)
* Age: 10 - 25 years
* Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives

Exclusion Criteria:

* Acute illnesses (e.g. infections) or major injuries
* Known chronic diseases (including psychological diagnoses) other than those mentioned above
* Surgery or blood transfusion in the last 3 months
* No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination
* Pregnancy; Breastfeeding
* Limited legal capacity

Primary outcomes:
measure: Personal data
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Clinical data
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Physical assessment
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Heart rate
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Blood pressure
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Questionnaire data
timeFrame: Measurement is taken at a single time point right after enrollment
measure: YSR questionnaire
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Imaging
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Full blood count
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Deformability Cytometer
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Virology
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Immunology
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Endocrinology
timeFrame: Measurement is taken at a single time point right after enrollment
measure: B-cell phenotyping
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Pain threshold
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Orthostasic Tolerance
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Grip strength
timeFrame: Measurement is taken at a single time point right after enrollment
measure: Smell test
timeFrame: Measurement is taken at a single time point right after enrollment
Secondary outcomes:
Other outcomes:
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