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| Name | Class |
|---|---|
| Norwegian University of Life Sciences | OTHER |
| University of Oslo | OTHER |
| Lund University | OTHER |
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The ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. The diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. However, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.
The ketogenic diet is a high-fat, moderate protein, low-carbohydrate diet. It is an internationally established treatment option in children with drug resistant epilepsy. About 40 -70 % of children with drug resistant epilepsy treated with the ketogenic diet achieve > 50 % seizure reduction. However, even though the ketogenic diet has been used in the treatment of epilepsy for almost a Century, little is known about how the dietary treatment reduces seizures and which patients that will respond well. In addition, there is limited knowledge about potential adverse effects of the treatment. This is a prospective study following the patients from 4 weeks before initiating the ketogenic diet and during the treatment. The influence of the dietary treatment on the gut microbiota, epigenetics, quality of life, and adverse effects will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet | Other | The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | Other | The patients follow the ordinary treatment protocol for ketogenic diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the gut microbiota | Changes in the gut microbiota composition in fecal samples from baseline to 12 weeks of dietary treatment will be measured by 16S rRNA analysis. | From baseline to 12 weeks of dietary treatment. |
| Characterization of DNA methylation | Changes in the DNA methylation in white blood cells from baseline to 12 weeks of dietary treatment will be analyzed using the Infinium Methylation EPIC Kit. | From baseline to 12 weeks of dietary treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in parental quality of life and parental perceptions of their child's quality of life | The impact of the dietary treatment on quality of life will be examined by using a questionaire before and after 12 weeks of dietary treatment. The quality of life score is a parental measure of the impact for the family, based on their hopes and expectations of the effects of the ketogenic diet.The quality of life is rate on a scale from 0 to 10 (0 = quality of life is poor, 10 = quality of life is very good) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaja K Selmer, PhD | Contact | 0047 22 11 77 83 | k.k.selmer@medisin.uio.no | |
| Sigrid Pedersen, MSc | Contact | 004767501491 | ketoprosjekt@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Kaja K Selmer, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 0424 | Norway |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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This is a prospective, non-randomized study
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| 12 weeks of dietary treatment. |
| Adverse effects | To identify potential adverse effects induced by the dietary treatment measured by a structured interview. | 12 weeks of dietary treatment. |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |