Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy

Withdrawn before enrolling

Conditions studied: Epilepsy

In brief

Research study to look for bio markers in epilepsy patients on ketogenic diet

Key facts

Study ID

NCT04311242

Run by

Senda Biosciences

People needed

0

Starts

2020-04-15

Expected to finish

2021-02-23

Last updated by the study team

2021-02-26

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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