NCT04705298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

January 5, 2021

Last Update Submit

March 7, 2022

Conditions

Drug Resistant Epilepsy

Keywords

Ketogenic DietGut MicrobiomeInulin

Outcome Measures

Primary Outcomes (2)

  • 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

    12 weeks

  • 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

    12 weeks

Secondary Outcomes (1)

  • Seizure frequency

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Prebiotic

EXPERIMENTAL

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

Dietary Supplement: Prebiotic

Interventions

PrebioticDIETARY_SUPPLEMENT

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

Prebiotic
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

NOT YET RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Central Study Contacts

Maksim Parfyonov, MD

CONTACT

7788635905info@epbiome.com

Linda Huh, MD

CONTACT

lhuh@cw.bc.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Division of Neurology

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 12, 2021

Study Start

June 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

CA(2)