Actively Recruiting
Management of Drug-resistant Epilepsy in Infants and Children Using the Ketogenic Diet and KetoCal4 Range in Real-life Care
Led by Nutricia Nutrition Clinique · Updated on 2024-01-24
133
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nutricia Nutrition Clinique
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of the KetoCal4 range to support the ketogenic diet in infants and children with drug-resistant epilepsy, aged from 5 months to just under 18 years. This study is observational and follows standard medical practice without changing existing treatments. The goal is to understand how well the KetoCal4 products help maintain the ketogenic diet and improve quality of life for these patients. The KetoCal4 range includes products with different fat-to-carbohydrate plus protein ratios (4:1 and 3:1), which contain vitamins, minerals, trace elements, and fiber. These can be taken orally as a drink, mixed into recipes, or given by feeding tube. The ketogenic diet will be started at the doctor's discretion, typically during hospitalization. This study collects real-life data on how patients use these products within their ongoing care. During the study, children and infants will be monitored for up to six months. Researchers will assess their adherence to the diet, how long they maintain it, its effectiveness, tolerance, quality of life changes, and achievement of ketosis. No additional medical treatments are imposed, and the only extra procedures involve completing quality of life questionnaires. The study aims to provide detailed observations on managing drug-resistant epilepsy using the ketogenic diet with KetoCal4.
CONDITIONS
Brief 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 and children up to 17 years of age (under 18 years).
- Diagnosis of drug-resistant epilepsy per ILAE criteria.
- Physician's indication for a ketogenic diet.
- Parents or legal guardians able to set up and follow the diet.
- Written consent from parent(s) or legal representative 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 a ketogenic diet.
- Receiving parenteral nutrition.
- Use of other special medical food products like KetoVie or Keyo.
- Legal representative under legal protection or deprived of liberty.
- Legal representative not covered by social security.
- Legal representative unable to understand the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants who undergo routine care with the ketogenic diet are observed to gather real-life data on compliance, efficacy, tolerance, and quality of life over time.
Regular visits as part of standard care
Trial Site Locations
Total: 1 location
1
CHRU Lille
Lille, France, 59037
Actively Recruiting
Research Team
E
Elmire DEGOUL-COMBESCOT, PhD
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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