This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and children up to 17 years of age (i.e. 18 years minus 1 day) with drug-resistant epilepsy.
This study is being conducted according to standard medical practice. No change in diagnostic or therapeutic management habits is imposed by this study. Quality of life questionnaires are the only additional procedures for this research.
Infants from 5 months and children up to 17 years of age (maximum 18 years minus 1 day).
With drug-resistant epilepsy according to ILAE (International League Against Epilepsy) criteria: persistence of epileptic seizures after failure of two appropriate antiepileptic drugs tried consecutively or in well-tolerated combination.
Indication for CR by a physician.
Parents (or legal guardians) able to set up and follow the diet, assessed during a joint doctor-dietician consultation.
Contraindication to ketogenic diet at initial assessment.
Children already on a ketogenic diet.
Parenteral nutrition.
Concurrent prescription of other foodstuffs intended for special medical purposes (DADFMS) such as KetoVie or Keyo.
A total of 133 eligible patients will be recruited in this project. The target population of our project will be infants (from 5 months of age) and children up to 18 years of age treated for drug-resistant epilepsy, who, depending on the physician in charge of the patient, may benefit from the initiation of a KetoCal® 3:1 or 4:1 CR, depending on the child's age. We exclude from our study protected legal representatives of minors (under guardianship, curatorship, minor parents). In addition, people taking part in this study will not be able to take part in any other interventional or observational research for the duration of the study. A 6-month exclusion period is planned as part of this project.
Other
Prospective
Ketocal
Other interventionketogene diet
Description of compliance
Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months.
Duration of compliance
Describe the duration of KD compliance.
Efficacy of KD
Describe the efficacy of KD. Efficacy is defined as responders to KD with seizure frequency reduced by more than 50%, or no seizure frequency in the case of total response to CR in the last week.
KD tolerance.
Describe KD tolerance as a number of AE reported
QoL evolution
Describe changes in patients' quality of life following initiation of KD at inclusion, and M6; using PedsQL ™ questionnaires
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Nutricia Nutrition Clinique
Lead sponsor
Euraxi Pharma
Collaborator
