Use of Betashot in Children and Adults With Epilepsy

Vitaflo International, Ltd77 enrolled

Overview

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: 1. Tolerance (side effects such as bloating or cramps) 2. Acceptability (flavour, texture, taste) 3. Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily diet)

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Nervous System Disorder

Interventions

BetashotDIETARY_SUPPLEMENT

Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. 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: 1. Children \< 3 years of age 2. Children and adults free from epilepsy for \> 4 weeks 3. Medical conditions that contra-indicate the use of MCT 4. Inability to comply with the study protocol. 5. Currently on a ketogenic diet 6. Children and adults who are totally enterally fed. 7. Females who are pregnant or planning to become pregnant during the study.

Locations (2)

National Hospital for Neurology and Neurosurgery

London, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom

Outcomes

Primary Outcomes

Palatability

The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot

Time frame: 12 weeks

Gastrointestinal tolerance

The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot

Time frame: 12 weeks

Compliance

The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot

Time frame: 12 weeks

Data from ClinicalTrials.gov

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