Use of Betashot in Children and Adults With Epilepsy

NCT02825745 | Completed

• 2 other identifiers: MCT-BETS-14082015-01181054
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

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.

Conditions

Nervous System Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Dietary Supplement: Betashot

Interventions

Betashot DIETARY_SUPPLEMENT

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

Also known as: MCT based emulsion

Betashot

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitaflo International, Ltd: lead

Study Sites (2)

National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Great Ormond Street Hospital for Children

London, United Kingdom

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Matthew Walker

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: July 7, 2016
• Study Start: June 29, 2016
• Primary Completion: May 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)