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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHRU Lille
RECRUITING
Lille
Contact Information
Primary
Elmire DEGOUL-COMBESCOT, PhD
Elmire.DEGOUL@danone.com
+33 (0) 6 27 91 97 08
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 133
Treatments
Patient
Infants (from 5 months) and children up to 17 years of age follow up for drug resistant epilepsy
Related Therapeutic Areas
Sponsors
Leads: Nutricia Nutrition Clinique
Collaborators: Euraxi Pharma

This content was sourced from clinicaltrials.gov