Role of the Gut Microbiota in Pediatric Epilepsy (EPBiome)

British Columbia Children's Hospital

Status and phase: Unknown; Phase 4

Conditions: Drug Resistant Epilepsy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Prebiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04705298

H19-01935

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for \>6 years

Treatment:

Dietary Supplement: Placebo

Prebiotic

Experimental group

Description:

Oligofructose-enriched inulin 4 grams daily for ≤ age 6; or 8 grams daily for \>6 years

Treatment:

Dietary Supplement: Prebiotic