RecruitingNot Applicable

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

Italy20 participantsStarted 2024-04-01

Plain-language 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

Age range3 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Epilepsy

Timeframe: Change at 3 months from baseline of each round of supplementation

Trial details

NCT IDNCT06448663

SponsorUniversity of Milan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

Contact for this trial

Aglaia Vignoli, MD

+390264443960 aglaia.vignoli@unimi.it

View on ClinicalTrials.gov More CDKL5 trials