Studies a ketogenic diet in children with epilepsy, autism, migraine or brain tumors
Observes children with genetic, neurological or metabolic conditions who follow a ketogenic diet.
Plain-language title generated from the registry record
Registry title: Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Key facts
- Where
- Milan, Pavia, and Roma, ItalySee the 3 sites
Where in Italy
- ASST Fatebenefratelli Sacco (PO "V. Buzzi")Milan, ItalyTaking people
- Fondazione "Istituto Neurologico Nazionale C. Mondino"Pavia, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Danone Nutricia SpA Società Benefit
- Trial code
- NCT06309251
- Record updated
- 3 September 2025
- Original description
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.Read full original descriptionShow less
Clinical and Nutritional Effectiveness and Impact on the Quality of Life of the Ketogenic Diet in Pediatric Patients With Neurological, Genetic or Metabolic Disorders: a Multicenter Prospective Observational Study
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
Inclusion: 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: 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.