A Potential New Therapy for Refractory Idiopathic Epilepsy in Dogs
Idiopathic epilepsy (IE) is a common disease in dogs. Up to 20-30% of these dogs are refractory to available therapies, and there is currently no cure for the disease. . The purpose of this study is to determine if Fecal Microbiome Transplantation (FMT) administered as a capsule, from healthy donors, will decrease episode frequency and severity due to gut microbiome changes.
Eligibility: Dogs will be included in the study if they meet the following criteria:
- Under 4 years of age
- Have a history of recurrent seizures for > 1 year
- Have a seizure frequency ≥ 1 per month for at least 2 consecutive months in which the dog was appropriately treated with two or more conventional antiepileptic drugs (AED).
- Refractory dogs will be required to either have had a serum phenobarbital or bromide concentration within a therapeutic range or be receiving the labeled dose of zonisamide or levetiracetam before being considered refractory. All AED given prior to the beginning of the study will be continued unchanged.
- They must also have had normal lab tests (CBC, serum biochemical analysis and bile acids), unremarkable findings on MRI of the brain and CSF analysis (if performed), and negative results of infectious disease testing. The amount of testing may vary due to owners’ consent at the time of diagnosis and the age and breed of the dog.
Compensation: The drug or placebo will be provided free of charge. The dogs in the placebo group will have the option of receiving 3 months of the FMT capsules at the end of the trial period as an incentive, if proven to show some improvement.
Any tests or procedures unrelated to the study are the responsibility of the owner.
OWNER RESPONSIBILITIES: If you agree to let your dog participate in this study, your dog will be randomly assigned to receive either FMT or a placebo. You will need to return to Cornell for monthly visits for follow-ups, blood and fecal sampling, and to receive the next month’s capsule supply for the duration of the trial period. (5 visits) Most importantly, we ask that you don’t make any changes in the dog’s medications or diet during the trial period (16 weeks), and for you to keep a seizure and medication log. (The logs will be provided to you.)
Principal Investigator: Yael Merbl, BSc, DVM, DECVN
Contact/Schedule an Appointment: Please contact the clinical trials coordinator team at 607.253.3060, or email vet-research@cornell.edu.