Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)

Launched by UNIVERSITY OF MILAN · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to help manage seizures in patients with CDKL5 Deficiency Disorder (CDD), a rare condition that often causes difficult-to-treat seizures. Researchers want to see if improving the balance of bacteria in the gut, known as the gut-microbiota-brain axis, can help reduce seizures and improve other related health issues for patients with CDD. The trial is currently recruiting participants of all genders, aged 3 to 50 years, who have a confirmed diagnosis of CDD and experience seizures that do not respond well to standard medications.

To be eligible, participants must have a confirmed genetic test showing a CDKL5 mutation and must have someone willing to help them throughout the study. However, those with certain gut-related health problems or who are on special diets will not be able to join. Participants can expect to receive support and monitoring during the trial, which aims to explore a potentially new way to help manage their condition. This study represents an exciting opportunity for patients and families affected by CDD to contribute to research that could lead to better treatment options.

Gender

ALL

Eligibility 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.