Improving seizure control in CDKL5 deficiency by targeting gut health
Targeting the Gut to Improve Seizure Control in CDD
This study is testing whether dietary supplements can help reduce seizures and improve health in people with CDKL5 deficiency disorder by focusing on gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years to 50 Years |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06448663 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential of targeting the gut-microbiota-brain axis to alleviate seizures and improve comorbidities in patients with CDKL5 deficiency disorder (CDD). Given the limited efficacy of standard anti-seizure medications in CDD, the research will explore the effects of dietary supplements, including alpha-lactalbumin and prebiotics, on neurological features and gut microbiota composition. Participants will be monitored for changes in seizure frequency and overall health outcomes as a result of these interventions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with CDKL5 deficiency disorder who experience drug-resistant seizures and have a caregiver's support.
Not a fit: Patients with organic gastrointestinal disorders or those on special diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment avenue for improving seizure control and quality of life in patients with CDKL5 deficiency disorder.
How similar studies have performed: While the gut-brain axis is a novel area of research in epilepsy, previous studies have shown promising results in related conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: clinical diagnosis of CDD and demonstrated CDKL5 pathogenic variant; drug-resistant seizures; ensured participation of a caregiver; willingness to sign the informed consent. Exclusion Criteria: organic GI disorders (i.e., food allergies, celiac disease); special diets; percutaneous endoscopic gastrostomy tube; use of antibiotics or probiotics in the previous month.
Where this trial is running
Milan
- University of Milan — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Aglaia Vignoli, MD — University of Milan
- Study coordinator: Aglaia Vignoli, MD
- Email: aglaia.vignoli@unimi.it
- Phone: +390264443960
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.