Status:
COMPLETED
Market Research - Acceptability Study for a Range of MCT Products
Lead Sponsor:
Dr. Schär AG / SPA
Conditions:
Ketosis
Epilepsy
Eligibility:
All Genders
2-60 years
Phase:
NA
Brief Summary
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 ye...
Eligibility Criteria
Inclusion
- Diagnosis of epilepsy or a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
- Subjects who are new to or already taking an MCT oil and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between new product trialled.
- Patients aged 3 years of age to adulthood.
- Written informed consent obtained from patient or parental caregiver.
Exclusion
- 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 less than 3 years of age.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04309149
Start Date
November 1 2018
End Date
January 31 2020
Last Update
March 16 2020
Active Locations (2)
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1
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
2
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL