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Role of the Gut Microbiota in Pediatric Epilepsy

NCT04705298 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-03-09

No results posted yet for this study

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.

Conditions

  • Drug Resistant Epilepsy

Interventions

DIETARY_SUPPLEMENT

Prebiotic

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • British Columbia Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705298 on ClinicalTrials.gov