About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ketocal
Treatment groups
Sponsors and collaborators
Nutricia Nutrition Clinique
Lead sponsor
Euraxi Pharma
Collaborator