Pentabiocel in Pediatric IBS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorUniversity of Roma La Sapienza
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pentabiocel
DrugThis 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
DrugThis 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: PentabiocelExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
IBS Severity Scoring System (IBS-SSS)
The primary outcome will be the improvement in severity of clinical presentation from baseline to 4 weeks afer the end of the treatment period. Score interpretation: Remission \< 75; Mild 75 -175; Moderate 175 - 300 ; Severe 300-500.
Time frame
4 month2
Bristol Stool Scale
A secondary outcome will be modifications of bowel habits from baseline to 4 weeks after the end of the treatment period. Scale interpretation: types 1 to 7. Types 1 and 2 constipation; types 3 and 4 ideal stools; types 6 and 7 diarrhea.
Time frame
4 months3
Gastrointestinal Symptom Rating Scale (GSRS)
A secondary outcome will be the improvement in the amount of GI symptoms from baseline to 4 weeks after the end of the treatment period. The GSRS is a disease-specific instrument of 15 items combined into 5 symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. 1 to 7 scale (1: absence of troublesome symptoms; 7: very troublesome symptoms).
Time frame
4 month4
IBS Quality of Life Questionnaire (IBS-QOL-34)
A secondary outcome will be the improvement in the quality of patients' lifestyle from baseline to 4 weeks after the end of the treatment period. IBS-QOL includes 34 items in a 5-point Likert scale with 8 subscales of dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual issues, and relations. The obtained scores range from 0 to 100 and it takes 10 min to complete. Higher scores indicate lower quality of life.
Time frame
4 monthSponsors and contacts
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Source ClinicalTrials.gov
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