i-EGM
Research type
Research Study
Full title
Impact of epilepsy medication on gut microbiome - i-EGM
IRAS ID
322697
Contact name
Rhys Thomas
Contact email
Sponsor organisation
Newcastle University
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Background
There are an estimated 10,000,000,000 bacterial cells from 1000 different species living within our gut. Termed the gut microbiome, this area of research has emerged as an important mechanism that works alongside nerve, hormone, metabolic and immune pathways. Several brain disorders demonstrate a gut-brain relationship, but the evidence is lacking for epilepsy.Hypothesis
What are the changes in gut microbiome profile when starting an anti-seizure medicine, and does this depend on the type of drug?Methods
We propose an observational study of adults with epilepsy starting antiepileptic medication. Choice of anti-seizure medications and titration schedule will be decided by the treating doctor.Recruitment will be through weekly specialist clinics at the Royal Victoria Infirmary. We aim to recruit 200 people with epilepsy, each with a paired control (cohabitant of similar diet). They will consent to research, be asked to fill in a brief diet questionnaire and be asked to provide a stool sample. This can be provided on the day, or more likely at home and sent back to us in the post using a specialised kit.
We will ask people for a second sample at an interval of three months to see which changes are temporary and which are permanent.Patient Impact
The pilot study will enable us to adequately power a clinical trial to look at the impact of anti-seizure drugs on the microbiome for people with chronic epilepsy, and whether certain profiles may be associated with seizure rates. The ambition is to find microbiome biomarkers of seizure outcome that can be manipulated.REC name
London - Bromley Research Ethics Committee
REC reference
23/LO/0461
Date of REC Opinion
23 Oct 2023
REC opinion
Further Information Favourable Opinion