Evaluating the ketogenic diet's effects on children with various conditions
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
This study is testing if the ketogenic diet can help children with conditions like epilepsy, autism, migraines, and brain tumors feel better and grow properly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Danone Nutricia SpA Società Benefit Industry-sponsored |
| Locations | 3 sites (Milan, MI and 2 other locations) |
| Trial ID | NCT06309251 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients under 18 years with drug-resistant epilepsy or other genetic, metabolic, or neurological conditions that require a ketogenic diet.
Not a fit: Patients with specific metabolic disorders affecting ketone metabolism or those with type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how the ketogenic diet can enhance the quality of life and clinical outcomes for children with various neurological and metabolic conditions.
How similar studies have performed: Previous studies have shown promising results for the ketogenic diet in treating drug-resistant epilepsy, but this study aims to explore its effects in a broader range of conditions, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, MI and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.