Clinical trial NCT04399954: Evaluation of Ketoflo
Official title: A Study to Evaluate the Acceptability of Ketoflo, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Epilepsy or Neurometabolic Conditions Requiring a Ketogenic Diet (KD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy Intractable
Glucose Transporter Type 1 Deficiency Syndrome
Ketogenic Dieting
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group - all patients to receive Ketoflo.
Primary purpose: SUPPORTIVE_CARE

Brief summary: For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a nutritionally complete Food For Special Medical Purposes and is suitable for administration by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants adherence to recommended intakes and their thoughts on the product's palatability will be self-reported in Daily Study Diaries.

Detailed description: This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI tolerance, adherence to recommended intakes and palatability. The product's nutritional suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and seizure frequency measured as part of usual clinical care.

Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy or other neurometabolic conditions requiring a ketogenic diet. It is designed to be nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.

Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional choice of prescribe-able feeds for use in the ketogenic diet.

The study will involve 30 participants, aged between three and eighteen years of age (inclusive), who are already established on a ketogenic diet for at least three months before the study begins.

Participants will self-report data in Daily Study Diaries over the course of the study. Data will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all participants. Any data collected for the study will be anonymised before being relayed to the sponsor.

The data generated by the trial will be used to support a submission by Vitaflo (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to become reimbursable on prescription in the UK. The data will also be used in a submission to the General Medical Services in the Republic of Ireland.

Eligibility criteria: Inclusion Criteria:

i) Diagnosis of a condition requiring a ketogenic diet (KD) e.g. intractable epilepsy, Glut-1 deficiency syndrome (Glut-1 DS) etc.

ii) Aged 3 - 18 years of age (inclusive).

iii) Established on a ketogenic diet for at least 3 months under the supervision of a clinician and/or dietitian trained in the use of the KD.

iv) Requirement for a liquid ketogenic feed.

v) In the opinion of the investigator, the participant (and parent/guardian, if relevant) is/are able to comply with the study protocol requirements and complete the diary and questionnaire.

vi) Willingly given, written, informed consent from participant (or parent/guardian, if relevant)

vii) Willingly given, written assent (if appropriate).

Exclusion Criteria:

i) Inability to comply with the study protocol, in the opinion of the investigator.

ii) Under 3 years of age or over 18 years of age.

iii) Medical conditions in which the KD is contraindicated.

iv) Previous clinical evaluation indicating unsuitability for the KD.

Primary outcomes:
measure: Change in gastrointestinal tolerance from week 1 to week 4
timeFrame: Days 1 - 7 and days 21 - 28.
measure: Adherence
timeFrame: Days 1 - 28.
measure: Palatability and ease of use
timeFrame: Day 28.
measure: Nutritional suitability: ketone levels
timeFrame: Days 1 - 28
measure: Nutritional suitability: seizure frequency
timeFrame: Days 1 - 28
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
city: Birmingham
country: United Kingdom
facility: Barberry
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Leeds
country: United Kingdom
facility: Leeds Children's Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Kathryn Lightfoot
role: STUDY_DIRECTOR
References: