Drug Resistant EpilepsyPhase 4EPBiomeNCT04705298
Role of the Gut Microbiota in Pediatric Epilepsy
A Phase 4 study testing Prebiotic in people with Drug Resistant Epilepsy, run by British Columbia Children's Hospital at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2021to 1 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
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- Aged 2-18.
- Immunocompetent.
- No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Linda Huh, MD contact
Canada2 sites, 2 recruiting
- Not yet recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Juan Pablo Appendino, MD, JP.Appendino@albertahealthservices.ca
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Maksim Parfyonov, MD, info@epbiome.com
About this study
Official title: Leveraging the Gut Microbiota in Pediatric Refractory Epilepsy: Safety and Feasibility of Oligofructose-enriched Inulin Supplementation for Dysbiosis and Seizure Control
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
- Drug Resistant Epilepsy
- Being tested
- Prebiotic, Placebo
- Keywords
- Ketogenic Diet, Gut Microbiome, Inulin
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Oligofructose-enriched inulin. 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
PlaceboDietary supplement
Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years Receives: Dietary Supplement: Placebo |
| Prebiotic | Experimental | Oligofructose-enriched inulin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks
Secondary outcomes (1)
Seizure frequency
Trends in seizure frequency during inulin treatment compared to pre-treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksim Parfyonov, British Columbia Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705298
- Sponsor's protocol ID
- H19-01935
- Acronym
- EPBiome
- Status last verified
- Mar 2022
- First submitted
- 5 Jan 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging the Gut Microbiota in Pediatric Refractory Epilepsy: Safety and Feasibility of Oligofructose-enriched Inulin Supplementation for Dysbiosis and Seizure Control
- ClinicalTrials.gov ID
- NCT04705298
- Acronym / sponsor ID
- EPBiome / H19-01935
- Conditions
- Drug Resistant Epilepsy
- Keywords
- Ketogenic Diet, Gut Microbiome, Inulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- British Columbia Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years |
| Prebiotic | Experimental | Dietary Supplement: PrebioticOligofructose-enriched inulin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
Key exclusion criteria (12 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticOligofructose-enriched inulin. 4 grams daily for ≤ age 6; or 8 grams daily for >6 years | Dietary supplement | Prebiotic |
| PlaceboMaltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years | Dietary supplement | Placebo |
Primary outcome
Change in alpha and beta bacterial diversity measures in stool
Time frame: 12 weeks
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
Time frame: 12 weeks
Compare the effect of inulin vs. placebo on SCFA levels in the stool of children undergoing ketogenic diet therapy for epilepsy
1 secondary outcome
Seizure frequency
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Huh, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prebiotic in people with Drug Resistant Epilepsy, run by British Columbia Children's Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maksim Parfyonov, MD (7788635905, info@epbiome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alpha and beta bacterial diversity measures in stool (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.