20
Participants
Start Date
April 1, 2024
Primary Completion Date
January 31, 2025
Study Completion Date
April 30, 2025
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."
RECRUITING
University of Milan, Milan
Fondazione Telethon
OTHER
Kolfarma s.r.l. - Italy
UNKNOWN
University of Milan
OTHER