Status:
UNKNOWN
Role of the Gut Microbiota in Pediatric Epilepsy
Lead Sponsor:
British Columbia Children's Hospital
Conditions:
Drug Resistant Epilepsy
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief Summary
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 tre...
Eligibility Criteria
Inclusion
- Children with epilepsy:
- Age 2-18.
- Attended the epilepsy clinic for a minimum of 6 months.
- On a stable number and type of medications for 4 weeks.
- Have not previously been on the ketogenic diet.
- Healthy controls:
- Aged 2-18.
- Immunocompetent.
- No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
Exclusion
- Health conditions such as disorders of fatty acid transport and oxidation, porphyria, and pancreatitis, Glucose transporter 1 deficiency, pyruvate dehydrogenase deficiency, diabetes, and other autoimmune diseases.
- Presence of HIV infection, chronic wound infection, or osteomyelitis
- Presence of or treatment for periodontal infection
- Inflammatory bowel disease, chronic diarrhea, current Clostridium difficile infection
- Treatment with immunosuppressive agents in the past 6 months
- Significant changes in dietary intake (i.e. excluded sugar, lactose or gluten from their diet, started consuming a vegetarian or vegan diet) over the past 6 months.
- Gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms.
- Use of antibiotics in the 3 months preceding the study.
- Use of probiotic or prebiotic supplements in the month preceding the study.
- Consumption of probiotic yoghurt in the past 2 weeks.
- Use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study.
- History of allergic reaction or intolerance of maltodextrin or inulin.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04705298
Start Date
June 1 2021
End Date
September 1 2022
Last Update
March 9 2022
Active Locations (2)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
2
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1