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.
Key facts
- Who runs it
- Danone Nutricia SpA Società Benefit
- Where
- Milan, Pavia, and Roma, ItalySee the 3 sites
- Trial code
- Registry title
- Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 1 Mar 2022
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Treatments tested
- ketogenic diet (as per clinical practice)
- Record updated
- 3 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers under 18 who are on a ketogenic diet for drug-resistant epilepsy or for a genetic, metabolic or neurological disease. Doctors follow them as in usual care.
- Age
- Under 18 years
- Sex
- All sexes
- Disease stage
- Drug-resistant epilepsy, meaning seizures not controlled after trying two or more seizure medicines. Or a genetic, metabolic or neurological disease, present from birth or acquired, treated with a ketogenic diet.
- Earlier treatment
- For drug-resistant epilepsy: no lasting seizure freedom after adequate trials of two or more antiseizure medications.
Main reasons for not taking part
- Beta-oxidation cycle disorders
- Systemic primary carnitine deficiency
- Primary dyslipidemia
- Pyruvate carboxylase deficiency
- Porphyria, mitochondrial disease, ketone body metabolism defects, gluconeogenesis defect, or type 1 diabetes
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Italy
- ASST Fatebenefratelli Sacco (PO "V. Buzzi")Milan, ItalyContact: Sara Olivotto, MDTaking people
- Fondazione "Istituto Neurologico Nazionale C. Mondino"Pavia, ItalyContact: Valentina De Giorgis, MDTaking people
- Ospedale Pediatrico Bambino GesùRoma, ItalyContact: Antonella Diamanti, MDTaking people
About the trial
What the trial wants to find out
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
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
The group in the trial
- Patients requiring KD
Pediatric patients with any disease which require a ketogenic diet (KD), i.e. metabolic or genetic disorder or neurological (congenital and acquired) diseases
Treatment: ketogenic diet (as per clinical practice)
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Studies a ketogenic diet in children with epilepsy, autism, migraine or brain tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 September 2025