Status:
RECRUITING
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
Lead Sponsor:
Nutricia Nutrition Clinique
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Drug Resistant Epilepsy
Ketogenic Dieting
Eligibility:
All Genders
5-18 years
Brief 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 i...
Detailed Description
NUTRICIA has developed the KetoCal® range (4:1 and 3:1), a food for special medical purposes (DADFMS), to help healthcare professionals and patients establish and maintain a CR. KetoCal® 4:1 features ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT06075485
Start Date
January 15 2024
End Date
June 1 2026
Last Update
January 24 2024
Active Locations (1)
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1
CHRU Lille
Lille, France, 59037