G93.3
Conditions
Interventions
Group 1: A prospective intervention is planned using a cross-over design with 40 PAIS patients, approximately 20 of whom have ME/CFS. The sample size of this pilot study is based on the number of PAIS
Sponsors
Universitätsklinik für Kinder- und Jugendmedizin Bielefeld
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: Physician-diagnosed post-acute infection syndrome (PAIS) and/or, additionally, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Moderate to severe disease severity (Bell Score > 10 and < 80). MAD and study questionnaires are feasible in terms of language proficiency, cognitive capacity, and logistics. Capability for online communication.
Exclusion criteria
Exclusion criteria: Presence of absolute contraindications for implementing a modified Atkins diet (MAD), including congenital disorders of mitochondrial fatty acid transport, fatty acid oxidation, gluconeogenesis, ketone body synthesis, and ketone body degradation. These metabolic disorders are either identified through newborn screening or associated with developmental neurological abnormalities. Some may no longer be relevant at the participant’s age; therefore, exclusion can be based on medical history and clinical assessment without additional investigations. Patients with pre-existing developmental disorders or epilepsy are also excluded. MAD is not feasible or practical for patients or their guardians due to insufficient social support, inadequate dietary habits, or frequent external meals (e.g., school cafeteria). Bell Score 70, according to clinical assessment by the study physician and patient self-assessment via questionnaire. Hemoglobin < 8 mg/dl, due to the required blood draws and subsequent differential diagnostics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of physical limitations in daily life (SF-36 Physical Function) | — |
Secondary
| Measure | Time frame |
|---|---|
| Core Symptoms and Neuropsychology Improvement of quality of life (PedsQL). Processing speed (Test battery for attention assessment). Fatigue (FSS). Post-Exertional Malaise (PEM) (PEM-DSQ). Symptom severity (Numerical rating scales from 1 to 10). EEG Activity: Frequency analysis of activity in the theta and delta ranges. Neuronal connectivity between different brain regions with coherence analysis. Microbiome/Metabolome: Diversity (a- and ß-diversity) and species distribution. Microbial metabolism (metabolomics analysis) of stool samples. Mitochondrial metabolism as part of dietary changes. Immunological Parameters: Immunophenotyping of human T-/NK-cells. Analysis of immune status. Functional metabolic analyses. Assessment of mitochondrial functionality and integrity. Adherence: Descriptive representation of periods with successful metabolic shift based on urine ketone test results. Questionnaire on feasibility and acceptance for patients and parents. | — |
Countries
Germany
Contacts
Public ContactGeorg Classen
Universitätsklinik für Kinder- und Jugendmedizin, Universitätsklinikum OWL der Universität Bielefeld
Outcome results
None listed