KetoSTrENgTH (KETOgenic diet aS TheRapy for mEtabolic and NeuroloGical condiTions in cHildren): a prospective observational multicenter study

Ketogenic diet therapies (KDTs) are nonpharmacological treatments that are effective in patients with metabolic disorders, drug-resistant epilepsy, migraine brain tumors and autism spectrum disorder (ASD) but perspective studies with an adequate study population, especially in the latter diseases, are lacking. Hence an Italian prospective observational study involving 3 referral KDTs Centers (Fondazione Mondino in Pavia, Buzzi Hospital in Milan, and Bambino Gesù Hospital in Rome) has been implemented to monitor clinical-nutritional efficacy in neurological diseases to whom KDT is a therapeutic option. We recorded follow-up evaluations in pediatric patients at T0 and then after 3, 6 and 12 months including: tolerability evaluations, blood nutritional parameters and body composition status; Quality of Life (QoL) questionnaires; efficacy measured as modification in number of seizures (epilepsy), number of days with headache and modification of PedMIDAS disability score (migraine), modification in CARS score (ASDs) and survivors in the observation period (brain tumors). In the first 6 months of follow-up, we enrolled 45 patients (21 with epilepsy, 17 with migraine, 6 metabolic disorders, 1 brain tumor). Therefore we report our preliminary data providing evidence that KDTs have therapeutic benefits in patients in developmental age with different neurological disorders confirming good tolerability, even in critical conditions, symptoms amelioration and ultimately improvement in QoL.