Role of the Gut Microbiota in Pediatric Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Drug Resistant Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic

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

Group Type EXPERIMENTAL

Prebiotic

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Prebiotic

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes