EDIBLE v1.0

• Research type

  Research Study

• Full title

  Full title: A randomised controlled trial to compare seizure remission outcome following resective surgery with or without prior treatment with ketogenic diet in children with epilepsy the result of Focal Cortical Dysplasia type II. Short title: Evaluating Dietary Intervention Before surgicaL treatment for Epilepsy Acronym: EDIBLE

• IRAS ID

  151063

• Contact name

  J Helen Cross

• Contact email

  h.cross@ucl.ac.uk

• Sponsor organisation

  UCL Joint Research Office

• Duration of Study in the UK

  4 years, 10 months, 30 days

• Research summary

  Can a Ketogenic Diet (KD) enhance the outcome of resective surgery in children with epilepsy the result of Focal Cortical Dysplasia (FCD) type II?

  FCD malformation is the main cause of drug-resistant epilepsy in children and resective brain surgery is a routinely used treatment. Surgery does not always result in seizure freedom. Other evidence suggests that a high fat content KD may decrease seizures in some patients.
  
  The EDIBLE study will compare changes in seizures after surgery between children that followed a KD or their usual diet before surgery. The study will help us find out if having a KD before surgery is any better at stopping seizures than surgery alone. Ultimately, the results of this study may help to optimise future routine treatment in children with epilepsy the result of FCD Type II.

  At least 120 children aged 5-15 years, diagnosed with drug-resistant epilepsy the result of FCD Type II and suggested to be treatable by resective surgery will be recruited. The study will be conducted in a number of tertiary paediatric epilepsy centres across Europe that routinely offer both resective brain surgery and a KD service as a treatment for complex epilepsy.

  Children will be followed-up every 3 months for the first 12 months and annually up to 48 months. Children will be equally and randomly divided into two groups. Both groups will have resective brain surgery but one of the groups will need to follow a KD for 6 months beforehand. The effect of a KD on seizures, Quality of Life, neuropsychological status and any potential influences on DNA related functions in tissue and blood samples will be examined.

  The EDIBLE study is part of a multinational European project investigating complex epilepsy in children, which is funded by the European Commission - Seventh Framework Programme.

• REC name

  London - Central Research Ethics Committee

• REC reference

  14/LO/1885

• Date of REC Opinion

  3 Nov 2014

• REC opinion

  Favourable Opinion