Pentabiocel in Pediatric IBS

NANot yet recruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2025

Conditions
Irritable Bowel Syndrome (IBS)Pediatrics
Interventions
DRUG

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."

DRUG

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."

Trial Locations (4)

20121

Ospedale Fatebenefratelli e Oftalmico, Milan

20129

Ospedale Macedonio Melloni, Milan

20157

Ospedale Sacco, Milan

00189

Azienda Ospedaliera Sant'Andrea, Rome

All Listed Sponsors
lead

University of Roma La Sapienza

OTHER

NCT06720805 - Pentabiocel in Pediatric IBS | Biotech Hunter | Biotech Hunter