Status:
WITHDRAWN
Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy
Lead Sponsor:
Senda Biosciences
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
1-18 years
Brief Summary
Research study to look for bio markers in epilepsy patients on ketogenic diet
Detailed Description
Epilepsy is a neurological disorder characterized by the recurrence of unprovoked seizures that affects approximately 3.4 million people in the United States (1.2% of the total United States populatio...
Eligibility Criteria
Inclusion
- Study participant and/or legal representative must be willing and able to give informed consent/assent for participation in the study.
- Study participant and/or legal representative must be willing and able to comply with all study requirements, in the opinion of the Investigator(s).
- Study participant is \<18 years of age at the Screening Visit.
- Study participant has refractory epilepsy.
Exclusion
- Study participant has a known cardiac disorder including arrhythmias or hypertension.
- Study participant has carnitine deficiency (primary), carnitine palmitoyltransferase I or II deficiency, or carnitine translocase deficiency.
- Study participant has beta-oxidation defects - medium-chain acyl dehydrogenase deficiency, long-chain acyl dehydrogenase deficiency, short-chain acyl dehydrogenase deficiency, long-chain 3-hydroxyacyl-coenzyme A deficiency, or medium-chain 3-hydroxyacyl-CoA deficiency.
- Study participant has a pyruvate carboxylase deficiency.
- Study participant has porphyria.
- Study participant is unable to maintain adequate nutrition.
- Study participant has a surgically remediable cause for refractory epilepsy.
- Study participant has a suspected mitochondrial disorder or has been diagnosed with a disorder in which a high-fat diet is contraindicated.
- Study participant has previously received a ketogenic diet or modified Atkins diet.
- Study participant has a chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired), or chronic respiratory illness.
- Study participant's family is expected to have compliance problems with treatment and/or seizure registration.
- Study participant's seizures are under acceptable control.
- Study participant has had a vagus nerve stimulator implanted within the last 18 months, has started a new antiepileptic drug (AED) within the last 2 months, or has changed his/her antiepileptic drugs within the last month.
- Study participant has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
- Study participant's nutritional status is not good enough or intake of fluid is too small to permit treatment with ketogenic diet.
- Study participant has, within the last 2 months, been using medications or herbal medicine that have a considerable effect on glucose metabolism, such as oral glucocorticoids.
- Study participant has, within the last 2 months, been using medications or herbal medicine that have a considerable effect on metabolism of AEDs.
- Study participant uses herbal medicine which can interact with AEDs or a ketogenic diet.
- Study participant has participated in another study of an investigational drug within the previous 3 months before Screening (or within 5 half-lives for the investigational drug, whichever is longer) or is currently participating in another study of an investigational drug.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 23 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04311242
Start Date
April 15 2020
End Date
February 23 2021
Last Update
February 26 2021
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02116