56
Participants
Start Date
December 1, 2024
Primary Completion Date
July 31, 2025
Study Completion Date
December 31, 2025
Pentabiocel
"This is a randomized, double-blind, placebo-controlled, multicenter clinical trial aimed at recruiting 56 pediatric patients with IBS.~The activities will be divided into the following phases:~1. Patient Enrollment Phase: eligible patients will meet the diagnostic criteria for IBS, as defined by internationally recognized guidelines. Informed consent will be obtained from the legal guardians of the participants before their inclusion in the study.~2. Randomization: the enrolled participants will be randomly assigned to one of two groups: the probiotic group or the placebo group.~3. Treatment Phase: a 3-month treatment phase will be conducted with a mixture of 5 strains of lactic acid bacteria and bifidobacter.~4. Follow-up Phase: this will be followed by a 4-week follow-up phase. Clinical data will be monitored throughout the study using validated questionnaires."
Placebo
"This is a randomized, double-blind, placebo-controlled, multicenter clinical trial aimed at recruiting 56 pediatric patients with IBS.~The activities will be divided into the following phases:~1. Patient Enrollment Phase: eligible patients will meet the diagnostic criteria for IBS, as defined by internationally recognized guidelines. Informed consent will be obtained from the legal guardians of the participants before their inclusion in the study.~2. Randomization: the enrolled participants will be randomly assigned to one of two groups: the probiotic group or the placebo group.~3. Treatment Phase: a 3-month treatment phase will be conducted with a mixture of 5 strains of lactic acid bacteria and bifidobacter.~4. Follow-up Phase: this will be followed by a 4-week follow-up phase. Clinical data will be monitored throughout the study using validated questionnaires."
Ospedale Fatebenefratelli e Oftalmico, Milan
Ospedale Macedonio Melloni, Milan
Ospedale Sacco, Milan
Azienda Ospedaliera Sant'Andrea, Rome
University of Roma La Sapienza
OTHER