28
Participants
Start Date
April 1, 2022
Primary Completion Date
February 28, 2023
Study Completion Date
February 28, 2023
ALAC, inulin, FOS, and sodium butyrate
Pre- and post-biotic supplementation will be administered for 3 month period (i.e. 12 weeks) given the filling out of a supplementation diary by parents/caregivers. At the scheduled visits/ phone contacts (i.e., baseline, 4 weeks and 12 weeks), systemic inflammation, intestinal inflammation, and gut microbiome characterization as well as treatment compliance, clinical and dietary intake will be assessed. A seizure diary will be provided to parents/caregivers in order to check the frequency and entity of the critical episodes. An EEG recording will be performed at enrollment (or within 6 months prior to the baseline visit).
Sodium butyrate and zinc oxide
Post-biotic supplementation will be administered for 3 month period (i.e. 12 weeks) given the filling out of a supplementation diary by parents/caregivers. At the scheduled visits/ phone contacts (i.e., baseline, 4 weeks and 12 weeks), systemic inflammation, intestinal inflammation, and gut microbiome characterization, as well as treatment compliance, clinical and dietary intake will be assessed. A seizure diary will be provided to parents/caregivers in order to check the frequency and entity of the critical episodes. An EEG recording will be performed at enrollment (or within 6 months prior to the baseline visit).
"Policlinico S. Maria alle Scotte Azienda Ospedaliera Universitaria Senese", Siena
Kolfarma s.r.l. - Italy
UNKNOWN
European Institute of Oncology
OTHER
Azienda Ospedaliera Universitaria Senese
OTHER