Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of a Multi-strain Probiotic in Pediatric Irritable Bowel Syndrome (PTB_IBS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 4
- Primary Endpoint
- Fecal Calprotectin Test
Study Overview
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.
Detailed Description
The rationale for this study stems from the need to address the limited treatment options available for pediatric patients with IBS. Current management strategies mainly involve dietary modifications, symptomatic therapy, and psychological interventions. Probiotics offer a promising additional therapy that could potentially improve clinical outcomes and enhance the quality of life for affected children.
The specific probiotic strain selected for this study has shown beneficial effects on gut health and immune function in preclinical and clinical studies. However, its effectiveness in pediatric patients with IBS remains unexplored. Therefore, this study aims to fill this research gap by evaluating the effect of this probiotic strain on symptom severity, bowel habits, and quality of life in pediatric IBS patients.
The findings of this study could provide valuable insights into the potential therapeutic role of probiotics in pediatric IBS and contribute to the development of evidence-based guidelines for managing this condition. Furthermore, it could pave the way for additional research exploring the mechanisms of action and long-term effects of probiotics in this population, ultimately improving the overall health and well-being of pediatric IBS patients.
The theoretical framework for this study centers on understanding the potential therapeutic role of probiotics in pediatric IBS. IBS is a common gastrointestinal disorder characterized by chronic abdominal pain and disrupted bowel habits. Its pathophysiology is multifactorial, involving changes 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 attracted attention as a potential treatment option for Irritable Bowel Syndrome (IBS). They have been shown to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects. While previous studies demonstrated the beneficial effects of probiotics in adult IBS patients, few studies have been conducted in the pediatric population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •. IBS diagnosis (all subtypes) according to Rome IV criteria
- •4 -17 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
Exclusion Criteria
- •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).
Arms & Interventions
Pentabiocel
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)
Intervention: Pentabiocel (Drug)
Placebo
Children with irritative bowel sindrome who received placebo once a day for 12 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Fecal Calprotectin Test
Time Frame: 3 months
The primary outcome measure will be fFC dosage to compare bowel inflammation levels from baseline to the end of the treatment period.
Secondary Outcomes
- 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)
Investigators
Prof. Giovanni Di Nardo
Professor
University of Roma La Sapienza