RecruitingNCT06309251

Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients

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


Sponsor

Danone Nutricia SpA Società Benefit

Enrollment

100 participants

Start Date

Mar 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the effectiveness and impact on quality of life of the ketogenic diet in children with epilepsy that doesn't respond well to medications, or in children with certain metabolic, genetic, or neurological conditions. The ketogenic diet is a high-fat, very low-carbohydrate eating plan that can help control seizures. **You may be eligible if...** - Your child is under 18 years old - Your child has epilepsy that hasn't been controlled by at least two anti-seizure medications, OR has a metabolic, genetic, or neurological condition being treated with the ketogenic diet - Your child may include those in intensive care for severe seizure episodes (status epilepticus) **You may NOT be eligible if...** - Your child has certain metabolic disorders involving fat breakdown or energy pathways (e.g., fatty acid oxidation defects, primary carnitine deficiency, pyruvate carboxylase deficiency) - Your child has Type 1 diabetes - Parents or caregivers cannot commit to following the strict dietary requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERketogenic diet (as per clinical practice)

Patients recruited receive a ketogenic diet. The prescription, the type of KD protocol and the route of administration will depend, essentially, on the patient's ability and willingness to feed spontaneously and independently, as well as on compliance with the therapies set and the severity of the clinical conditions.


Locations(3)

ASST Fatebenefratelli Sacco (PO "V. Buzzi")

Milan, MI, Italy

Fondazione "Istituto Neurologico Nazionale C. Mondino"

Pavia, PV, Italy

Ospedale Pediatrico Bambino Gesù

Roma, RM, Italy

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NCT06309251


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