Pentabiocel in Pediatric IBS

NCT06720805 | Not Yet Recruiting

• 1 other identifier: PTB_IBS
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Irritable Bowel Syndrome (IBS); Bifidobacterium; Visceral hypersensitivity; microbiome; Lactobacillus; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Fecal Calprotectin Test

  The primary outcome measure will be fFC dosage to compare bowel inflammation levels from baseline to the end of the treatment period.

  3 months

Secondary Outcomes (4)

• IBS Severity Scoring System (IBS-SSS)

  4 month

• Bristol Stool Scale

  4 months

• Gastrointestinal Symptom Rating Scale (GSRS)

  4 month

• IBS Quality of Life Questionnaire (IBS-QOL-34)

  4 month

Study Arms (2)

Pentabiocel

EXPERIMENTAL

Children with IBS who received probiotics once a day for 12 weeks. Every sachet contains: * Lactobacillus casei LMG 101/37P-17504 (5Å109 CFU/sachet) * Lactobacillus plantarum CECT 4528 (5Å109 CFU/sachet) * Bifidobacterium animalis subsp. lactis Bi1 LMG P- 17502 (10Å109 CFU/sachet) * Bifidobacterium breve Bbr8 LMG P-17501 (10Å109 CFU/sachet) * Bifidobacterium breve Bl10 LMG P-17500 (10Å\~109 CFU/sachet)

Drug: Pentabiocel

Placebo

PLACEBO COMPARATOR

Children with irritative bowel sindrome who received placebo once a day for 12 weeks

Drug: Placebo

Interventions

Pentabiocel DRUG

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.

Pentabiocel

Placebo DRUG

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

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• IBS diagnosis (all subtypes) according to Rome IV criteria
• years of age
• endoscopy examination (with bioptic samples) negative for IBD or microscopic colitis
• negative anti-transglutaminase antibodies
• capability to follow the protocol
• Signature of informed consent

You may not qualify if:

• Presence of chronic, chromosomal, or congenital anomalies, autoimmune diseases, metabolic diseases, or immunodeficiencies.
• Patients with concomitant conditions that may cognitively impair their understanding of study instructions and their ability to provide informed consent.
• Current use of non-steroidal anti-inflammatory drugs, corticosteroids, and mast cell stabilizers, use of topical or systemic antibiotics in the past month, continuous use of stimulant laxatives, major abdominal surgery, inflammatory bowel disease, infectious diarrhea, allergic diseases, and other organic or psychiatric disorders.
• Patients with concomitant organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, cancer) or a major illness such as diabetes or uncontrolled thyroid disease.
• Patients with a history of intestinal surgery (excluding appendectomy or cholecystectomy).

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (4)

Ospedale Fatebenefratelli e Oftalmico

Milan, 20121, Italy

Location

Ospedale Macedonio Melloni

Milan, 20129, Italy

Location

Ospedale Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, 00189, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Giovanni Di Nardo, Professor, MD

CONTACT

+39 3397267637; giovanni.dinardo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

IT (4)