Plain-English translation of NCT06448663 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing whether alpha-lactalbumin combined with specific prebiotics and postbiotics can help reduce seizures and improve symptoms in people with CDKL5 deficiency disorder (CDD). CDD is a rare genetic condition that causes severe, hard-to-control seizures starting in infancy, along with developmental delays and other neurological challenges. The study is based on recent research showing that people with this condition have differences in their gut bacteria, and that changing the gut microbiome may help control seizures better than current medications alone.
Standard anti-seizure medications don't work well enough for most CDD patients, leaving them with ongoing seizures that interfere with development and quality of life. Recent research has discovered that the gut microbiome (the bacteria living in your digestive system) plays a role in seizure control, and CDD patients have abnormal gut bacteria composition—suggesting that this treatment approach might offer a new way to help.
You will participate in this 32-week study at a single site. The study has two 12-week treatment periods separated by a 4-week break. During each period, you'll take one of two supplement combinations—one containing the base supplements, and the other adding an extra ingredient called sodium butyrate. You'll likely have clinic visits to provide samples (such as stool samples to check your gut bacteria) and to track changes in your seizures and symptoms over time.
AI-generated summary from trial data · Jun 4, 2026 · Not medical advice
Italy
Sponsor
University of Milan
Collaborators
Fondazione Telethon, Kolfarma s.r.l. - Italy
Enrollment target
~20 participants
Started
April 2024
Primary completion
January 2025
Age range
3 Years – 50 Years
Last updated on clinicaltrials.gov in June 2024.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Aglaia Vignoli, MD
University of Milan