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Use of Betashot in Children and Adults With Epilepsy

Primary Purpose

Nervous System Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Betashot
Sponsored by
Vitaflo International, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nervous System Disorder

Eligibility Criteria

3 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Hospital for Neurology and Neurosurgery
  • Great Ormond Street Hospital for Children

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Betashot

Arm Description

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.

Outcomes

Primary Outcome Measures

Palatability
The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot
Gastrointestinal tolerance
The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot
Compliance
The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot

Secondary Outcome Measures

Full Information

First Posted
September 7, 2015
Last Updated
May 18, 2020
Sponsor
Vitaflo International, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02825745
Brief Title
Use of Betashot in Children and Adults With Epilepsy
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitaflo International, Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nervous System Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Betashot
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Betashot
Other Intervention Name(s)
MCT based emulsion
Intervention Description
Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.
Primary Outcome Measure Information:
Title
Palatability
Description
The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot
Time Frame
12 weeks
Title
Gastrointestinal tolerance
Description
The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot
Time Frame
12 weeks
Title
Compliance
Description
The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Walker
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Use of Betashot in Children and Adults With Epilepsy

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