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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04705298
Other study ID # H19-01935
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2021
Est. completion date September 1, 2022

Study information

Verified date March 2022
Source British Columbia Children's Hospital
Contact Maksim Parfyonov, MD
Phone 7788635905
Email info@epbiome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Prebiotic
Oligofructose-enriched inulin. 4 grams daily for = age 6; or 8 grams daily for >6 years
Placebo
Maltodextrin 4 grams daily for = age 6; or 8 grams daily for >6 years

Locations

Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada BC Children's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
British Columbia Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Seizure frequency Trends in seizure frequency during inulin treatment compared to pre-treatment. 12 weeks
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