Epilepsy Clinical Trial
Official title:
Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso) Kanso DeliMCT 53% (Cream) Kanso DeliMCT 28% (Tomato or Mushroom) Kanso DeliMCT 21% (Cacaobar)
Verified date | March 2020 |
Source | Dr. Schär AG / SPA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
Status | Completed |
Enrollment | 12 |
Est. completion date | January 21, 2019 |
Est. primary completion date | January 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 20 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of epilepsy requiring a ketogenic or a specialist diet as part of their treatment. - Subjects new to taking or who are already taking an MCT product and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between each new product trialled. - Those patients who have been taking MCT in their diet should do so for a minimum of 4 weeks before commencement of the study. - Patients aged 3 years of age to adulthood. - Written informed consent obtained from patient or parental caregiver. Exclusion Criteria: - Presence of serious concurrent illness - Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements - Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study - Any patients having taken antibiotics over the previous 2 weeks leading up to the study - Patients already on and MCT product who have been taking it in their diet for less than 4 weeks - Patients less than 3 years of age - Patients over 20 years. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Aberdeen Children's Hospital | Aberdeen | Grampian |
Lead Sponsor | Collaborator |
---|---|
Dr. Schär AG / SPA |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal tolerance | Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product | 7 days for each product, maximum 25 days | |
Primary | Product compliance | Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. | 7 days for each product, maximum 25 days | |
Primary | Product palatability | Questionnaire data captured to evaluate taste | 7 days for each product, maximum 25 days | |
Primary | Product acceptability | Brief tick-box questionnaire on overall liking and acceptability of product | 7 days for each product, maximum 25 days |
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