Trials / Unknown
UnknownNCT04705298
Role of the Gut Microbiota in Pediatric Epilepsy
Leveraging the Gut Microbiota in Pediatric Refractory Epilepsy: Safety and Feasibility of Oligofructose-enriched Inulin Supplementation for Dysbiosis and Seizure Control
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- British Columbia Children's Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
- First posted
- 2021-01-12
- Last updated
- 2022-03-09
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04705298. Inclusion in this directory is not an endorsement.