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Evaluation of Ketoflo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399954
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Vitaflo International, Ltd

Brief Summary:
For 28 days, 15 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.

Condition or disease Intervention/treatment Phase
Epilepsy Intractable Glucose Transporter Type 1 Deficiency Syndrome Ketogenic Dieting Dietary Supplement: Ketoflo Not Applicable

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 15 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group - all patients to receive Ketoflo.
Masking: None (Open Label)
Masking Description: No masking, product will be given open label.
Primary Purpose: Supportive Care
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)
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Experimental: Ketoflo
Ketoflo to be incorporated into each participant's usual ketogenic diet for 28 days. Amount taken and frequency of intake to be determined by the dietitian.
Dietary Supplement: Ketoflo
Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.




Primary Outcome Measures :
  1. Change in gastrointestinal tolerance from week 1 to week 4 [ Time Frame: Days 1 - 7 and days 21 - 28. ]
    Participants will self-report any gastrointestinal symptoms experienced over the course of the study in Daily Study Diaries.

  2. Adherence [ Time Frame: Days 1 - 28. ]
    Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.

  3. Palatability and ease of use [ Time Frame: Day 28. ]
    Participants will answer questions relating to Ketoflo's palatability and ease of use following the end of the study.

  4. Nutritional suitability: ketone levels [ Time Frame: Days 1 - 28 ]
    Ketoflo's nutritional suitability will be assessed by evaluating ketone levels (mmol/l) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.

  5. Nutritional suitability: seizure frequency [ Time Frame: Days 1 - 28 ]
    Ketoflo's nutritional suitability will be assessed by evaluating seizure frequency (number per day) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399954


Contacts
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Contact: Joe Fahy 01517099020 ext 241 Joe.Fahy@Vitaflo.co.uk
Contact: Erika Brennan 1517099020 ext 262 Erika.Brennan@vitaflo.co.uk

Locations
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United Kingdom
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom, BS2 8BJ
Contact: Camille Newby         
Leeds Children's Hospital Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Kathryn Lightfoot         
Sponsors and Collaborators
Vitaflo International, Ltd
Investigators
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Study Director: Kathryn Lightfoot Leeds Teaching Hospitals NHS Trust
Principal Investigator: Victoria Whiteley Manchester University NHS Foundation Trust
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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT04399954    
Other Study ID Numbers: MCT-KFLO-2018-02-19
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases