Status:
WITHDRAWN
Comparison of Microbiome Composition and Biomarkers in Pharmaco Resistant and Pharmaco-Sensitive Epilepsy
Lead Sponsor:
Senda Biosciences
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Epilepsy in Children
Pharmaco-Resistant Epilepsy
Eligibility:
All Genders
1-18 years
Brief Summary
The purpose of this study is to determine stool microbiome composition and biomarkers that are differentially abundant and those that are associated with response to treatment (eg, anticonvulsant drug...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- Study participant and/or legal representative is willing and able to give informed consent/assent for participation in the study.
- Study participant and/or legal representative is willing and able to comply with all study requirements, in the opinion of the Investigator.
- Study participant is between the ages of 12 and 21, inclusive, at the Screening Visit.
- Study participant resides at home (alone or with family).
- Study participant has a confirmed diagnosis of epilepsy (epilepsy groups only; not applicable to sibling controls).
- Study participant has continued unprovoked seizures despite trials of ≥2 appropriate antiepileptic drugs at therapeutic doses (pharmaco resistant epilepsy group only; not applicable to pharmaco sensitive epilepsy group or sibling controls).
Exclusion
- Study participant has monogenic epilepsy.
- Study participant has a neurodegenerative disease, mitochondrial disease, metabolic disease, active central nervous system disease, active autoimmune disease, or active inflammatory bowel disease.
- Study participant is on, or has been on within 30 days prior to the Screening Visit, a ketogenic diet, low glycemic index diet, or modified Atkins diet therapy.
- Study participant has had surgery within 3 months of the Screening Visit.
- Study participant is a resident in a group or hospital setting.
- Study participant requires the use of a g-tube or formula feeding.
- Study participant has had antibiotic therapy within 60 days prior to the Screening Visit.
- Study participant has participated in the study of an investigational product within 3 months prior to the Screening Visit (or within 5 half lives of the investigational product, whichever is longer) or is currently participating in a study of an investigational product.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04308252
Start Date
March 15 2020
End Date
March 15 2022
Last Update
February 26 2021
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02116