Role of the Gut Microbiota in Pediatric Epilepsy

Drug Resistant Epilepsy Clinical Trial

— EPBiome  

Official title:

Leveraging the Gut Microbiota in Pediatric Refractory Epilepsy: Safety and Feasibility of Oligofructose-enriched Inulin Supplementation for Dysbiosis and Seizure Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705298
• Other study ID #: H19-01935
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

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