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Nearly a third of children with epilepsy are refractory to pharmacotherapy. The ketogenic diet (KD) is a highly effective alternative therapy reducing seizure frequency by 50% in more than half of treated children. The exact mechanisms of KD remain poorly understood, and recent studies have implicated the gut microbiota (GM). This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotic fiber in children with epilepsy. The investigators hypothesize that consumption of inulin will alter gut microbiota and may have effects on seizure frequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years |
|
| Prebiotic | Experimental | Oligofructose-enriched inulin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary Supplement | Oligofructose-enriched inulin. 4 grams daily for ≤ age 6; or 8 grams daily for >6 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in alpha and beta bacterial diversity measures in stool | Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing ketogenic diet therapy for epilepsy | 12 weeks |
| Change in Short Chain Fatty Acid (SCFA) levels in stool | Compare the effect of inulin vs. placebo on SCFA levels in the stool of children undergoing ketogenic diet therapy for epilepsy | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency | Trends in seizure frequency during inulin treatment compared to pre-treatment. | 12 weeks |
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Inclusion Criteria:
Children with epilepsy:
Healthy controls:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maksim Parfyonov, MD | Contact | 7788635905 | info@epbiome.com | |
| Linda Huh, MD | Contact | lhuh@cw.bc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Not yet recruiting | Calgary | Alberta | T3B 6A8 | Canada |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Placebo | Dietary Supplement | Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years |
|
| BC Children's Hospital | Recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
|
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |