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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and children up to 17 years of age (i.e. 18 years minus 1 day) with drug-resistant epilepsy.
This study is being conducted according to standard medical practice. No change in diagnostic or therapeutic management habits is imposed by this study. Quality of life questionnaires are the only additional procedures for this research.
NUTRICIA has developed the KetoCal® range (4:1 and 3:1), a food for special medical purposes (DADFMS), to help healthcare professionals and patients establish and maintain a CR. KetoCal® 4:1 features a 4:1 ratio of fat to (carbohydrate + protein), while containing vitamins, minerals, trace elements and fiber. Similarly, KetoCal® 3:1 has a 3:1 ratio of lipids / (carbohydrates + proteins), while containing vitamins, minerals, trace elements and fiber. The KetoCal® range can be consumed orally, as a drink after dilution in hot water, incorporated as an ingredient in a recipe or administered by enteral feeding tube.
The KEOPS study is designed to gather real-life data on the therapeutic value of using the KetoCal® range in the management of drug-resistant epilepsy in infants (from 5 months) and children up to 18 years of age. Patients will be managed according to standard care practices. Initiation of ketogenic dieting will be at the investigator's discretion during the child's hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Infants (from 5 months) and children up to 17 years of age follow up for drug resistant epilepsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketocal | Other | ketogene diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of compliance | Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of compliance | Describe the duration of KD compliance. | From Month 1 to Month 6 |
| Efficacy of KD | Describe the efficacy of KD. Efficacy is defined as responders to KD with seizure frequency reduced by more than 50%, or no seizure frequency in the case of total response to CR in the last week. |
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Inclusion Criteria:
Exclusion Criteria:
Ancillary study eligibility criteria :
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A total of 133 eligible patients will be recruited in this project. The target population of our project will be infants (from 5 months of age) and children up to 18 years of age treated for drug-resistant epilepsy, who, depending on the physician in charge of the patient, may benefit from the initiation of a KetoCal® 3:1 or 4:1 CR, depending on the child's age.
We exclude from our study protected legal representatives of minors (under guardianship, curatorship, minor parents). In addition, people taking part in this study will not be able to take part in any other interventional or observational research for the duration of the study. A 6-month exclusion period is planned as part of this project.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elmire DEGOUL-COMBESCOT, PhD | Contact | +33 (0) 6 27 91 97 08 | Elmire.DEGOUL@danone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Lille | Recruiting | Lille | 59037 | France |
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| From Month 1 to Month 6 |
| KD tolerance. | Describe KD tolerance as a number of AE reported | From inclusion to Month 6 |
| QoL evolution | Describe changes in patients' quality of life following initiation of KD at inclusion, and M6; using PedsQL ™ questionnaires | From inclusion to Month 6 |
| Influence of KD | Total number of antiepileptic drugs used for each child including their current treatment until the end of the study. | From inclusion to Month 6 |
| Ketosis achievement | Evaluate the time it takes to achieve ketosis. Ketosis will be assessed by ketonuria or ketonemia, depending on the habits of each center. | From inclusion to Month 6 |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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