Protective Role of Pre-/ Post-biotics on Gut Inflammation, Dysbiosis, and Life Quality in Rett Syndrome (Biotics_RTT)

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
Rett SyndromeDysbiosisEpilepsyQuality of Life
Interventions
DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

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).

Trial Locations (1)

53100

"Policlinico S. Maria alle Scotte Azienda Ospedaliera Universitaria Senese", Siena

All Listed Sponsors
collaborator

Kolfarma s.r.l. - Italy

UNKNOWN

collaborator

European Institute of Oncology

OTHER

lead

Azienda Ospedaliera Universitaria Senese

OTHER