Comparison of Microbiome Composition and Biomarkers in Pharmaco Resistant and Pharmaco-Sensitive Epilepsy

Withdrawn before enrolling

Conditions studied: Epilepsy in Children, Pharmaco-Resistant Epilepsy

In brief

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 drugs).

Key facts

Study ID

NCT04308252

Run by

Senda Biosciences

People needed

0

Starts

2020-03-15

Expected to finish

2022-03-15

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 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.