Clinical trial NCT04705298: Role of the Gut Microbiota in Pediatric Epilepsy
Official title: Leveraging the Gut Microbiota in Pediatric Refractory Epilepsy: Safety and Feasibility of Oligofructose-enriched Inulin Supplementation for Dysbiosis and Seizure Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug Resistant Epilepsy
Keywords: Ketogenic Diet
Gut Microbiome
Inulin
Lead sponsor: British Columbia Children's Hospital
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: * Inclusion Criteria:

  * Children with epilepsy:

    1. Age 2-18.
    2. Attended the epilepsy clinic for a minimum of 6 months.
    3. On a stable number and type of medications for 4 weeks.
    4. Have not previously been on the ketogenic diet.
  * Healthy controls:

    1. Aged 2-18.
    2. Immunocompetent.
    3. No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
* Exclusion Criteria:

  1. 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.
  2. Presence of HIV infection, chronic wound infection, or osteomyelitis
  3. Presence of or treatment for periodontal infection
  4. Inflammatory bowel disease, chronic diarrhea, current Clostridium difficile infection
  5. Treatment with immunosuppressive agents in the past 6 months
  6. 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.
  7. Gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms.
  8. Use of antibiotics in the 3 months preceding the study.
  9. Use of probiotic or prebiotic supplements in the month preceding the study.
  10. Consumption of probiotic yoghurt in the past 2 weeks.
  11. Use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study.
  12. History of allergic reaction or intolerance of maltodextrin or inulin.

Primary outcomes:
measure: Change in alpha and beta bacterial diversity measures in stool
timeFrame: 12 weeks
measure: Change in Short Chain Fatty Acid (SCFA) levels in stool
timeFrame: 12 weeks
Secondary outcomes:
measure: Seizure frequency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
References: