RecruitingOBSERVATIONAL

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, called KEOPS, is for infants (from 5 months old) and children up to 18 years old who have severe epilepsy that hasn't improved with standard medicines. It aims to understand how a special medical food called KetoCal helps maintain a ketogenic diet in these children. The ketogenic diet is a high-fat, low-carbohydrate diet used to help control seizures. Researchers want to see how KetoCal works in real life when doctors and dietitians use it as part of their usual care. This isn't a trial where new treatments are tested; it observes how existing treatments are used. The main extra activity for families will be answering quality of life questionnaires.

At a glance

Status

Recruiting

Sponsor

Nutricia Nutrition Clinique

Enrolment target

133

Start

15 Jan 2024

Estimated completion

01 Jun 2026

Drug Resistant Epilepsy Ketogenic Dieting

What is this study about?

This study is called KEOPS, and it's looking into how a special diet, known as the ketogenic diet, helps children with a very specific type of epilepsy. This is epilepsy that hasn't responded to at least two standard seizure medications, which doctors call 'drug-resistant epilepsy'. The ketogenic diet is a medical treatment that can help control seizures in some children, and it involves carefully managing what they eat — specifically, it's a high-fat, low-carbohydrate approach.

To make it easier for children to follow this diet, a company called NUTRICIA has developed a product range called KetoCal. These are special medical foods designed to provide the right balance of fats, carbohydrates, proteins, vitamins, and minerals needed for the ketogenic diet. The KEOPS study wants to see how these KetoCal products are used by doctors and families in everyday life, and how helpful they are in managing seizures and supporting children's overall health.

It's important to understand that this study isn't asking doctors to change the way they normally treat epilepsy. Instead, it's observing what's already happening in hospitals and clinics. Doctors will decide if the ketogenic diet is right for a child, and if so, how to start it. The study will simply collect information on how the KetoCal products are used within these normal care plans for children aged 5 months to 18 years old with drug-resistant epilepsy.

Key takeaways

This study observes real-life use of the ketogenic diet and KetoCal for severe epilepsy in children.
It's for infants (5 months) and children up to 18 whose seizures haven't responded to other medicines.
Your child will receive their usual medical care, there are no new treatments involved.
The main extra activity is completing quality of life questionnaires.
The findings could help improve care for other children with drug-resistant epilepsy.

Who may be eligible?

To be considered for this study, your child needs to be between 5 months and 17 years old (just under 18). They must have drug-resistant epilepsy, which means their seizures haven't gotten better after trying at least two different anti-epilepsy medicines. A doctor must also have decided that the ketogenic diet is a good treatment option for your child.

It's important that you, as a parent or legal guardian, feel able to manage and follow the special diet for your child. A doctor and a dietitian will discuss this with you. You'll also need to give written permission for your child's information to be collected for the study, and your child must be part of the social security system in the UK.

Your child won't be able to join if they have any health conditions that make the ketogenic diet unsafe, or if they are already on a ketogenic diet. Children who are receiving nutrition directly into their veins (parenteral nutrition) or are using other specific medical food products, like KetoVie or Keyo, also can't take part. There are also rules about legal guardianship and your ability to understand how the study works.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 5 months and 17 years old?
Has your child's epilepsy not improved with at least two other medicines?
Has a doctor suggested the ketogenic diet for your child?
Are you able to manage your child's special diet?
Does your child have UK social security coverage?
Is your child NOT already on a ketogenic diet?

Answer every question to see your result.

What does participation involve?

If your child takes part, their doctors will decide if the ketogenic diet is suitable for them and how to start it, just as they normally would. This might happen while your child is in the hospital. The study doesn't involve any changes to your child's usual diagnostic tests or treatments. The main extra activity for you and your child will be completing questionnaires about their quality of life. These questionnaires are the only additional procedures for this research.

There's also an optional 'ancillary' (additional) part of the study. If your child stays on the ketogenic diet for at least two months and you give extra permission, they might be included in this deeper look. The total duration of participation isn't specified, but it's based on how long your child continues on the ketogenic diet under their usual medical care.

Potential risks and benefits

This study is mainly observational, meaning it watches how current treatments are used. This means there are no new medical treatments or procedures involved, which helps keep risks very low. The main 'benefit' is that it helps doctors and researchers better understand how the ketogenic diet and KetoCal products work in real-life settings for children with drug-resistant epilepsy, which could improve care for others in the future. As with any study, you have the right to withdraw your child at any time without it affecting their medical care.

Locations (1)

CHRU Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is the ketogenic diet?

It's a special high-fat, low-carbohydrate diet that some doctors use to help control seizures in children with certain types of epilepsy.

What is KetoCal?

KetoCal is a range of special medical food products designed to help children follow the ketogenic diet by providing the right balance of nutrients.

Is this study testing a new drug?

No, this study isn't testing new drugs. It's observing how established treatments, like the ketogenic diet and KetoCal, are used in everyday medical care.

What will my child have to do if they join?

Your child will receive their usual medical care. The main extra activity will be for you to fill out questionnaires about your child's quality of life.

Can I leave the study at any time?

Yes, you are free to withdraw your child from the study at any point, and it will not affect their medical treatment.

How to find out more

Elmire DEGOUL-COMBESCOT, PhD

elmire.degoul@danone.com +33 (0) 6 27 91 97 08 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.