Drug Resistant EpilepsyAutism Spectrum DisorderChronic MigraineBrain Tumor, Pediatric
Investigational drug(s) / intervention(s)
ketogenic diet (as per clinical practice)
ketogenic diet (as per clinical practice): Patients recruited receive a ketogenic diet. The prescription, the type of KD protocol and the route of administration will depend, essentially, on the patient's ability and willingness to feed spontaneously and independently, as well as on compliance with the therapies set and the severity of the clinical conditions.
Study summary
The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.
The main question\[s\] it aims to answer are:
* does KD support adequate growth?
* does KD improve clinical symptoms?
* how does KD impact quality of life? Participants will be followed up as per clinical practice
Eligibility
Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Pediatric patients (aged \< 18 years) with drug-resistant epilepsy (fail to achieve (and maintain) seizure freedom with adequate trials of two or more antiseizure medications) or genetic, metabolic, neurological (congenital and acquired) diseases treated with ketogenic diet
* Pediatric patients (aged \< 18 years) with metabolic, genetic or neurological (congenital and acquired) diseases (not necessarily associated with drug-resistant epilepsy) treated with ketogenic diet; this includes the new KD indications or the administration of KD in the ICU for status epilepticus.
Exclusion Criteria:
* Patients affected by beta-oxidation cycle disorders, systemic primary carnitine deficiency, primary dyslipidemia, pyruvate carboxylase deficiency, porphyria, mitochondrial disease, defects in ketone body metabolism (ketogenesis or ketolysis), defect in gluconeogenesis.
* Children with type 1 diabetes
* Parents (or caregivers) unable to guarantee adherence to the
Primary outcome measure(s)
Nutritional adequacy — 6 months evaluate the nutritional adequacy of the diet after 6 months of treatment with ketogenic diet (KD) in terms of adequate growth defined by weight-for-age Z Score (WAZ) and length-for-age Z score (LAZ).
Trial sites (3)
Facility
City
Region
Status
ASST Fatebenefratelli Sacco (PO "V. Buzzi")
Milan
MI
Recruiting
Fondazione "Istituto Neurologico Nazionale C. Mondino"
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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