Observational study of the effect of immunoadsorption (IA) in patients < 18 years of age with ME/CFS with evidence of autoantibodies

Observational study of the effect of immunoadsorption (IA) in patients < 18 years of age with ME/CFS with evidence of autoantibodies - BIAKI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032963

Enrollment

Registered

2023-10-31

Start date

2023-11-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G93.3

Interventions

Group 1: Study participants will be recruited from the group of pediatric patients who are scheduled for immunoadsorption due to ME/CFS in the setting. SF-36 Health Status, Bell Score, Munich Berlin S

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients aged 12 to <18 years with the clinical picture of ME/CFS diagnosed according to the Canadian Consensus Criteria (CCC) adapted for children. Written informed consent from patients and legal guardians Detection of autoantibodies (AAK) (adrenergic antibodies, ANA, antineuronal antibodies, or AAK to G protein-coupled receptors (GPCR) or others. Planned immunoadsorption with the TheraSorb®-Ig omni column over 5 treatment days.

Exclusion criteria

Exclusion criteria: Lack of willingness to store pseudonymized disease data as part of the study. Other medical conditions that do not allow the diagnosis to be secured (e.g., heart failure, pulmonary disease, major depression, cancer) Acute infection

Design outcomes

Primary

Measure	Time frame
The primary study objective is to compare physical functioning over 12 months after IA (monthly surveys) with before IA, as the main comparison 2 weeks before IA with 3 months after IA, by the SF 36- Physical Function (PF) Questionnaire (continuous score).	—

Secondary

Measure	Time frame
Change in symptom severity (Bell Score and Munich Berlin Symptom Questionnaire for children). Change in fatigue (Fatigue Severity Scale or PedsQL-MFS) Change in quality of life (EQ5D-Y) Other secondary outcome measures will be recorded once before and once after IA: Change in fatigue and vegetative symptoms (Chalder Fatigue Scale, COMPASS-31). Change in participation (CASP) Change in well-being/mental health Change in well-being and participation of family caregivers Other secondary study objectives include: Describe the study population and their previous care Observation of the tolerability of IA and any side effects Recording of the recurrence frequency over 12 months	—

Measure

Time frame

Change in symptom severity (Bell Score and Munich Berlin Symptom Questionnaire for children). Change in fatigue (Fatigue Severity Scale or PedsQL-MFS) Change in quality of life (EQ5D-Y) Other secondary outcome measures will be recorded once before and once after IA: Change in fatigue and vegetative symptoms (Chalder Fatigue Scale, COMPASS-31). Change in participation (CASP) Change in well-being/mental health Change in well-being and participation of family caregivers Other secondary study objectives include: Describe the study population and their previous care Observation of the tolerability of IA and any side effects Recording of the recurrence frequency over 12 months

—

Countries

Germany

Contacts

Public ContactWolfgang Ries

Medizinische Klinik, Diako Flensburg

rieswo@diako.de#494618121308

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026