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

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

January 31, 2025

Study Completion Date

April 30, 2025

Conditions
CDKL5
Interventions
DIETARY_SUPPLEMENT

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."

DIETARY_SUPPLEMENT

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."

Trial Locations (1)

Unknown

RECRUITING

University of Milan, Milan

All Listed Sponsors
collaborator

Fondazione Telethon

OTHER

collaborator

Kolfarma s.r.l. - Italy

UNKNOWN

lead

University of Milan

OTHER