NCT06309251 Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
| NCT ID | NCT06309251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danone Nutricia SpA Società Benefit |
| Condition | Drug Resistant Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06309251 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309251 currently recruiting?
Yes, NCT06309251 is actively recruiting participants. Contact the research team at antonella.diamanti@opbg.net for enrollment information.
Where is the NCT06309251 trial being conducted?
This trial is being conducted at Milan, Italy, Pavia, Italy, Roma, Italy.
Who is sponsoring the NCT06309251 clinical trial?
NCT06309251 is sponsored by Danone Nutricia SpA Società Benefit. The trial plans to enroll 100 participants.
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