Role of the Gut Microbiota in Pediatric Epilepsy (EPBiome)
Primary Purpose
Drug Resistant Epilepsy
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Prebiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring Ketogenic Diet, Gut Microbiome, Inulin
Eligibility Criteria
Inclusion Criteria:
Children with epilepsy:
- Age 2-18.
- Attended the epilepsy clinic for a minimum of 6 months.
- On a stable number and type of medications for 4 weeks.
- Have not previously been on the ketogenic diet.
Healthy controls:
- Aged 2-18.
- Immunocompetent.
- No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
Exclusion Criteria:
- 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.
- Presence of HIV infection, chronic wound infection, or osteomyelitis
- Presence of or treatment for periodontal infection
- Inflammatory bowel disease, chronic diarrhea, current Clostridium difficile infection
- Treatment with immunosuppressive agents in the past 6 months
- 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.
- Gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms.
- Use of antibiotics in the 3 months preceding the study.
- Use of probiotic or prebiotic supplements in the month preceding the study.
- Consumption of probiotic yoghurt in the past 2 weeks.
- Use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study.
- History of allergic reaction or intolerance of maltodextrin or inulin.
Sites / Locations
- Alberta Children's Hospital
- BC Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Prebiotic
Arm Description
Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
Oligofructose-enriched inulin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
Outcomes
Primary Outcome Measures
Change in alpha and beta bacterial diversity measures in stool
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing ketogenic diet therapy for epilepsy
Change in Short Chain Fatty Acid (SCFA) levels in stool
Compare the effect of inulin vs. placebo on SCFA levels in the stool of children undergoing ketogenic diet therapy for epilepsy
Secondary Outcome Measures
Seizure frequency
Trends in seizure frequency during inulin treatment compared to pre-treatment.
Full Information
NCT ID
NCT04705298
First Posted
January 5, 2021
Last Updated
March 7, 2022
Sponsor
British Columbia Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04705298
Brief Title
Role of the Gut Microbiota in Pediatric Epilepsy
Acronym
EPBiome
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy
Keywords
Ketogenic Diet, Gut Microbiome, Inulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
Oligofructose-enriched inulin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic
Intervention Description
Oligofructose-enriched inulin. 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
Primary Outcome Measure Information:
Title
Change in alpha and beta bacterial diversity measures in stool
Description
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing ketogenic diet therapy for epilepsy
Time Frame
12 weeks
Title
Change in Short Chain Fatty Acid (SCFA) levels in stool
Description
Compare the effect of inulin vs. placebo on SCFA levels in the stool of children undergoing ketogenic diet therapy for epilepsy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Seizure frequency
Description
Trends in seizure frequency during inulin treatment compared to pre-treatment.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with epilepsy:
Age 2-18.
Attended the epilepsy clinic for a minimum of 6 months.
On a stable number and type of medications for 4 weeks.
Have not previously been on the ketogenic diet.
Healthy controls:
Aged 2-18.
Immunocompetent.
No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
Exclusion Criteria:
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.
Presence of HIV infection, chronic wound infection, or osteomyelitis
Presence of or treatment for periodontal infection
Inflammatory bowel disease, chronic diarrhea, current Clostridium difficile infection
Treatment with immunosuppressive agents in the past 6 months
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.
Gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms.
Use of antibiotics in the 3 months preceding the study.
Use of probiotic or prebiotic supplements in the month preceding the study.
Consumption of probiotic yoghurt in the past 2 weeks.
Use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study.
History of allergic reaction or intolerance of maltodextrin or inulin.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maksim Parfyonov, MD
Phone
7788635905
Email
info@epbiome.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Huh, MD
Email
lhuh@cw.bc.ca
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Pablo Appendino, MD
Email
JP.Appendino@albertahealthservices.ca
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksim Parfyonov, MD
Email
info@epbiome.com
12. IPD Sharing Statement
Learn more about this trial
Role of the Gut Microbiota in Pediatric Epilepsy
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