EpilepsyNCT04311242
Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy
An observational study of Epilepsy, run by Senda Biosciences at 1 site in United States.
Trial summary
Research study to look for bio markers in epilepsy patients on ketogenic diet Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Diet
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 23 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
Study population: 50 epilepsy patients
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02116
About this study
Research study to look for bio markers in epilepsy patients on ketogenic diet
Read the 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
- Being tested
- Diet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Ketogenic diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome features associated with Ketogenic Diet response
Bacterial species and metabolomics biomarkers associated with patients responding to Ketogenic Diet
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start15 Apr 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Why it stopped: Sponsor decision to not pursue epilepsy development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senda Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311242
- Sponsor's protocol ID
- E-NEU-EPY-01
- Status last verified
- Feb 2021
- First submitted
- 16 Dec 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Composition and Biomarker Discovery in Refractory Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT04311242
- Acronym / sponsor ID
- E-NEU-EPY-01
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to not pursue epilepsy development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Senda BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 50 epilepsy patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietKetogenic diet | Other | – |
Primary outcome
Microbiome features associated with Ketogenic Diet response
Time frame: 24 months
Bacterial species and metabolomics biomarkers associated with patients responding to Ketogenic Diet
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Senda Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome features associated with Ketogenic Diet response (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.