Clinical Research Directory
Browse clinical research sites, groups, and studies.
Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)
Sponsor: University of Milan
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.
Official title: Targeting the Gut to Improve Seizure Control in CDD
Key Details
Gender
All
Age Range
3 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-04-01
Completion Date
2025-04-30
Last Updated
2024-06-07
Healthy Volunteers
No
Conditions
Interventions
alpha-lactalbumin, fructooligosaccharides, inulin
The first round supplementation will be administered for 3-month period (i.e. 12 weeks). One dose/day (2g sachet) is intended to be administered orally once a day after dissolving in water. At the scheduled visits/phone contacts \[i.e., baseline, 12 weeks, and 16 weeks (post washout)\], seizure frequency and entity of the critical episodes will be recorded. Gut microbiome characterization, clinical scales and dietary intake will be assessed.
alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin
The second round supplementation will be administered for 3-month period (i.e. 12 weeks). For participants weighing \<30 kg, a 4 g dose (i.e., one 4 g sachet) is intended to be administered orally once a day after dissolving in water. For participants weighing ≥30 kg, a 4 g dose (i.e., 4 g sachets) is intended to be administered orally twice a day (12h interval) after dissolving in water. At the scheduled visits/phone contacts \[i.e., 28 weeks and 32 weeks (post washout)\], seizure frequency and entity of the critical episodes will be recorded. Gut microbiome characterization, clinical scales and dietary intake will be assessed.
Locations (1)
University of Milan
Milan, Italy