Pentabiocel in Pediatric IBS

Summary

Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, including diarrhea, constipation, or a combination of both. It is estimated to affect about 10-20% of the global population, with a higher prevalence among children and adolescents. The pathophysiology of IBS is multifactorial and involves alterations in the gut microbiota, visceral hypersensitivity, and abnormal gastrointestinal motility. Probiotics, defined as live microorganisms that provide health benefits when administered in adequate amounts, have emerged as a potential therapeutic option for IBS due to their ability to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects.

Several studies have shown the beneficial effects of probiotics in adult IBS patients; however, few studies have been conducted in the pediatric population.

Thus, the investigators designed a randomized, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of a 12-week probiotic treatment with a blend of 5 strains of lactic acid bacteria and bifidobacteria in pediatric patients with Irritative Bowel syndrome.

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.

Sponsors & Collaborators

• University of Roma La Sapienza

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2025-07-31

Completion

2025-12-31

Countries

• Italy

Study Locations