NCT04311242

Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Senda Biosciences · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: —

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 population) and more than 65 million people globally. The most commonly used treatments for epilepsy are antiepileptic drugs (AEDs); however, approximately 25% to 30% of the epilepsy population is considered pharmaco-resistant (characterized by the failure of ≥2 appropriately chosen and dosed AEDs). Recent research suggests that the intestinal microbiota plays a central role in human health, and may play a role in a variety of central nervous system disorders, including seizure susceptibility. The microbiota has been shown to be associated with changes in factors relevant to neurotransmission, including neurotransmitter signaling, synaptic protein expression, long-term potentiation, and myelination. In addition to the microbiota's potential role in general neurotransmission, research suggests that the gut microbiome may differ between patients with pharmaco-resistant and pharmaco-sensitive epilepsies. Diet has been explored as an alternative form of therapy for patients with epilepsy, with the ketogenic diet showing promise as an alternative treatment for patients with drug-resistant epilepsy.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Diet	Ketogenic diet

Timeline

• Start date: 2020-04-15
• Primary completion: 2021-02-23
• Completion: 2021-02-23
• First posted: 2020-03-17
• Last updated: 2021-02-26

Locations

1 site across 1 country: United States