Actively 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
Led by Nutricia Nutrition Clinique · Updated on 2024-01-24
133
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
N
Nutricia Nutrition Clinique
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants from 5 months to children under 18 years of age
- Diagnosed with drug-resistant epilepsy according to ILAE criteria
- Indicated for ketogenic diet therapy by a physician
- Parents or legal guardians able to set up and follow the diet
- Written consent from parents or legal guardians to collect personal data
- Infant or child covered by social security system
You will not qualify if you...
- Contraindication to ketogenic diet at initial assessment
- Children already on ketogenic diet
- Receiving parenteral nutrition
- Using other special medical food products like KetoVie or Keyo
- Legal representative under legal protection or deprived of liberty
- Legal representative without social security coverage
- Legal representative unable to understand the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHRU Lille
Lille, France, 59037
Actively Recruiting
Research Team
E
Elmire DEGOUL-COMBESCOT, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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