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| ID | Type | Description | Link |
|---|---|---|---|
| 181054 | Other Identifier | IRAS |
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In brief, this research is a prospective, feasibility study to evaluate the use of Betashot- a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children and adults diagnosed with epilepsy.
MCT is a type of dietary fat used in the ketogenic diet.
This study aims to explore the use of Betashot in a group of children and adults with epilepsy who are consuming their normal diets, but limiting intakes of foods high in carbohydrate and sugars.
The participants will be required to drink Betashot to enable the following assessment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betashot | Other | Children:will take Betashot as a proportion of their daily energy requirements calculated from the dietary information obtained during Visit A for up to 12 weeks. Adults:will introduce Betashot and increase the amount taken in ml incrementally for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betashot | Dietary Supplement | Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Palatability | The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot | 12 weeks |
| Gastrointestinal tolerance | The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot | 12 weeks |
| Compliance | The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot | 12 weeks |
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Inclusion Criteria:
Children aged 3-18 years with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication, either with a diagnosis of Dravet syndrome or another early onset epilepsy, the result of a genetic mutation.
Adults (aged over 18) with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication.
Participant/Parent/guardian to comply with the study protocol and participate in active monitoring of tolerance, acceptability and compliance of Betashot via a written record, and to complete questionnaires.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Walker | UCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital for Neurology and Neurosurgery | London | WC1N 3BG | United Kingdom | |||
| Great Ormond Street Hospital for Children |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| London |
| United Kingdom |