RecruitingNCT06075485

Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance

Sponsor

Nutricia Nutrition Clinique

Enrollment

133 participants

Start Date

Jan 15, 2024

Study Type

OBSERVATIONAL

Conditions

Drug Resistant Epilepsy Ketogenic Dieting

Summary

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

Min Age: 5 MonthsMax Age: 18 Years

Inclusion Criteria6

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.
Written authorization from one (or both) parents or the child's legal representative to collect personal information about their child.
Affiliation of the infant/child with the social security system.

Exclusion Criteria11

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.
Protected legal representative (under legal protection, or deprived of liberty by judicial or administrative decision).
Legal representative not covered by a social security scheme.
Legal representative unable to understand study protocol.
Ancillary study eligibility criteria :
Patients included in the study.
Continued on the ketogenic diet for at least 2 months.
Having consented to participate in the ancillary study.