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

Launched by NUTRICIA NUTRITION CLINIQUE · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of the ketogenic diet to help manage drug-resistant epilepsy in infants and children. Drug-resistant epilepsy means that a child continues to have seizures even after trying at least two different medications that should have helped. The trial aims to gather information about the effectiveness of a specific product called KetoCal®, which supports the ketogenic diet, in maintaining seizure control. The study is taking place in multiple centers across France and is designed to follow patients over time to see how well the diet works for them.

To be eligible for this trial, children must be between 5 months and 17 years old and must have been diagnosed with drug-resistant epilepsy. Their parents or guardians need to be ready to help set up and follow the ketogenic diet, and they must agree to allow the collection of their child's health information. Participants will not face any changes to their usual medical care, but they will be asked to fill out questionnaires about their quality of life. This study is currently recruiting participants, so if you think your child may qualify, it could be a great opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.