Use of Betashot in Children and Adults With Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Tolerance (side effects such as bloating or cramps) Acceptability (flavour, texture, taste) Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily diet)

Official Title
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A Feasibility Study of the Use of Betashot, a Medium Chain Triglyceride- Based (MCT) Food for Special Medical Purposes (FSMP) in Children and Adults With Epilepsy.

Conditions
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Nervous System Disorder

Intervention / Treatment
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* Dietary Supplement: Betashot


Participation Criteria
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Eligibility Criteria
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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: Children < 3 years of age Children and adults free from epilepsy for > 4 weeks Medical conditions that contra-indicate the use of MCT Inability to comply with the study protocol. Currently on a ketogenic diet Children and adults who are totally enterally fed. Females who are pregnant or planning to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Betashot<br>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. | Dietary Supplement: Betashot<br>* Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.<br>* Other names: MCT based emulsion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |