A study focused at identifying disrupted biological factors and patient-tailored interventions for adolescents with Q-Fever Fatigue Syndrome

A study focused at identifying disrupted biological factors and patient-tailored interventions for adolescents with Q-Fever Fatigue Syndrome - Fatigue study in QFS, CFS and childhood arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55036

Enrollment

140

Registered

2020-06-16

Start date

2020-10-22

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Chronic Fatigue Syndrome Q-Fever Fatigue Syndrome

Interventions

All recruited patients (subgroups) and control groups start with a baseline assessments (T0): • The biological material (blood, saliva, faeces) is collected at study start (please see below for more

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: For all subjects: • Age of 12-29 years old • Able to speak, read, understand and write Dutch Inclusion criteria for QFS-patients: • Diagnosed with QFS according to the Dutch Guidelines • Fatigue lasting for at least 6 months • Debilitating fatigue which started before the age of 18, with detrimental effects on daily functioning (work and/or private situation) • Seropositive for C. Burnetii • No diagnoses of chronic Q-fever, recent diagnostics (39 Inclusion criteria for CFS/ME: • CFS/ME diagnosis according to the CDC criteria before the age of 18 • No diagnosis of QFS • Fatigue severity subscale (CIS8) score >39 Inclusion criteria for JIA: • Diagnosed with JIA, at least 3 months on stable medication and a stable disease activity score (JADAS-criteria) • No diagnosis of QFS • Expressing fatigue as a major complaint before the age of 18 • CIS8 score >34 (mean + 1 SD) • Being fatigued for at least 3 months Siblings/friends (healthy individuals): • Not severely fatigued (CIS8

Exclusion criteria

Exclusion criteria: • Diagnosis of chronic Q-fever ánd active disease • Cognitive impairment, estimated IQ

Design outcomes

Primary

Measure	Time frame
Objective 1: Biological parameters (e.g. immunological profile, HPA axis, mitochondrial dysfunctioning, gut microbiome) Objective 2: Fatigue severity based on the weekly outcome measurements on the smartphone is the primary outcome. Objective 3: Fatigue severity based on the weekly outcome measurements on the smartphone. Objective 4: Fatigue and all (personalized) fatigue associated factors assessed in the personalized EMA questionnaires. Objective 5: Fatigue severity based on the weekly outcome measurements on the smartphone and change in the biological profile at interval T0, T2, T4.	—

Measure

Time frame

Objective 1: Biological parameters (e.g. immunological profile, HPA axis, mitochondrial dysfunctioning, gut microbiome) Objective 2: Fatigue severity based on the weekly outcome measurements on the smartphone is the primary outcome. Objective 3: Fatigue severity based on the weekly outcome measurements on the smartphone. Objective 4: Fatigue and all (personalized) fatigue associated factors assessed in the personalized EMA questionnaires. Objective 5: Fatigue severity based on the weekly outcome measurements on the smartphone and change in the biological profile at interval T0, T2, T4.

—

Secondary

Measure	Time frame
Objective 1: none. Objective 2: quality of life and self-efficacy based on questionnaires at T0-T4. Objective 3: quality of life and self-efficacy based on VAS-items of weekly smartphone measurement. Objective 4: none. Objective 5: none.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026