Investigating gut microbiota in children with epilepsy on a ketogenic diet
The Role of Gut Microbiota in Children With Epilepsy Following Ketogenic Diet
This study is testing how a special diet might change the gut bacteria in children with epilepsy to see if those changes help control their seizures better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Athens, Haidari) |
| Trial ID | NCT05898438 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the changes in gut microbiota in children aged 2-18 years with epilepsy who are eligible for a ketogenic diet. Participants will provide stool samples before and three months after starting an olive oil-based ketogenic diet therapy. The study seeks to determine if specific populations of gut microorganisms are linked to improved seizure control in these children. Additionally, a parent of each participant will also contribute a fecal sample for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-18 years with drug-resistant epilepsy or specific metabolic conditions requiring a ketogenic diet.
Not a fit: Patients with systematic diseases such as inflammatory bowel disease, cancer, autoimmune disorders, or those currently taking antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how gut microbiota influence seizure control, potentially leading to improved dietary interventions for children with epilepsy.
How similar studies have performed: While some studies have suggested a link between gut microbiome and seizure control, this specific investigation into the ketogenic diet's impact on gut microbiota is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * type of epilepsy requiring ketogenic diet (drug-resistant epilepsy or Glut 1 DS or PDHD) * eligibility for ketogenic diet according to ILAE * no antibiotic intake for at least 2 months before the beginning of the study * no probiotics or prebiotics intake for at least 2 weeks before the beginning of the study Exclusion Criteria: - systematic diseases (e.g. inflammatory bowel disease, cancer, autoimmune and cardiometabolic diseases)
Where this trial is running
Athens, Haidari
- Attikon Athens University Hospital — Athens, Haidari, Greece (Recruiting)
Study contacts
- Study coordinator: Sofia D Zouganeli
- Email: szouganeli@attikonhospital.gr
- Phone: 00306979147890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.