Using the KetoCal® range to manage drug-resistant epilepsy in infants and children
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
This study is testing if the KetoCal® products can help infants and children with drug-resistant epilepsy stick to a ketogenic diet and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 133 (estimated) |
| Ages | 5 Months to 18 Years |
| Sex | All |
| Sponsor | Nutricia Nutrition Clinique Industry-sponsored |
| Locations | 1 site (Lille) |
| Trial ID | NCT06075485 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study aims to evaluate the therapeutic value of the KetoCal® range in maintaining a ketogenic diet for infants and children with drug-resistant epilepsy. The study will involve patients from 5 months to 17 years of age, who will be managed according to standard medical practices without altering their treatment plans. Quality of life questionnaires will be administered to gather additional data on the diet's effectiveness. The KetoCal® products are designed to support the dietary needs of these patients while being flexible in administration methods.
Who should consider this trial
Good fit: Ideal candidates are infants and children aged 5 months to 17 years with drug-resistant epilepsy who can adhere to a ketogenic diet.
Not a fit: Patients who have contraindications to a ketogenic diet or are already on such a diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve seizure control and quality of life for children with drug-resistant epilepsy.
How similar studies have performed: Previous studies have shown promising results with ketogenic diets in managing epilepsy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lille
- CHRU Lille — Lille, France (Recruiting)
Study contacts
- Study coordinator: Elmire DEGOUL-COMBESCOT, PhD
- Email: Elmire.DEGOUL@danone.com
- Phone: +33 (0) 6 27 91 97 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.