Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy

NCT04311242 | Withdrawn

• 1 other identifier: E-NEU-EPY-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Microbiome features associated with Ketogenic Diet response

  Bacterial species and metabolomics biomarkers associated with patients responding to Ketogenic Diet

  24 months

Interventions

Diet OTHER

Ketogenic diet

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 epilepsy patients

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.

Sponsors & Collaborators

• Senda Biosciences: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02116, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collecting blood and stool

MeSH Terms

Conditions

Epilepsy

Interventions

Diet

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: March 17, 2020
• Study Start: April 15, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

US (1)