Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)
Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD). The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities.
| Condition(s) | CDKL5 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD). The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities. |
| Who can participate | 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. |
| Ages | 3 Years to 50 Years |
| Sex | All |
| Lead sponsor | University of Milan |
| Locations | Milan, Italy |
| Start date | 2024-04-01 |
| NCT ID | NCT06448663 |
| Official listing | https://clinicaltrials.gov/study/NCT06448663 |