75
Participants
Start Date
July 2, 2019
Primary Completion Date
November 2, 2022
Study Completion Date
November 17, 2023
Experimental: Oxygen-Ozone (O2-O3)
Oxygen-Ozone (O2-O3) treatment by rectal insufflations for 5 weeks (3 sessions for week).
Active Comparator: Oxygen (O2)
Oxygen (O2) treatment by rectal insufflations for 5 weeks (3 sessions for week).
Placebo Comparator: Placebo (Air)
Air treatment by rectal insufflations for 5 weeks (3 sessions for week).
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia
IRCCS Centro San Giovanni di Dio Fatebenefratelli
OTHER