Evaluating the ketogenic diet's effects on children with various conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the clinical and nutritional effectiveness of the ketogenic diet (KD) in pediatric patients with conditions such as drug-resistant epilepsy, autism spectrum disorder, chronic migraine, and brain tumors. It will explore whether KD supports adequate growth, improves clinical symptoms, and impacts the quality of life. Participants will be monitored according to standard clinical practices, focusing on both the effectiveness of KD and its nutritional implications. The study seeks to fill gaps in existing research regarding the broader applications of KD beyond epilepsy.

Why it matters

Who can join: the full rules

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

Where it's running

• ASST Fatebenefratelli Sacco (PO "V. Buzzi")
  Milan, Mi, Italy Recruiting
• Fondazione "Istituto Neurologico Nazionale C. Mondino"
  Pavia, Pv, Italy Recruiting
• Ospedale Pediatrico Bambino Gesù
  Roma, Rm, Italy Recruiting

Study contacts

• Study coordinator: Antonella Diamanti, MD
• Email: antonella.diamanti@opbg.net
• Phone: +39 06 6859 2189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.