Pentabiocel in Pediatric IBS
Key facts
- Who runs it
- University of Roma La Sapienza
- Where
- Milan and Rome, ItalySee the 4 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 56 people, planned
- Started
- 1 Dec 2024
- Planned end
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Pentabiocel
- Placebo
- Record updated
- 6 December 2024
Who can take part
- Age
- 4 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- . 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
Who cannot take part
- Patients with concomitant conditions that may cognitively impair their understanding of study instructions and their ability to provide informed consent
- Patients with concomitant organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, cancer) or a major illness such as diabetes or uncontrolled thyroid disease
- Presence of chronic, chromosomal, or congenital anomalies, autoimmune diseases, metabolic diseases, or immunodeficiencies
- 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 a history of intestinal surgery (excluding appendectomy or cholecystectomy)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 17 years old?
Where in Italy
- Ospedale Fatebenefratelli e OftalmicoMilan, ItalyContact: Giovanni Di Nardo, Professor, MDNo longer taking part
- Ospedale Macedonio MelloniMilan, ItalyContact: Giovanni Di Nardo, Professor, MDNo longer taking part
- Ospedale SaccoMilan, ItalyContact: Giovanni Di Nardo, Professor, MDNo longer taking part
- Azienda Ospedaliera Sant'AndreaRome, ItalyContact: Giovanni Di Nardo, Professor, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- PentabiocelTreatment being tested
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)
- PlaceboPlacebo, for comparison
Children with irritative bowel sindrome who received placebo once a day for 12 weeks
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of a Multi-strain Probiotic in Pediatric Irritable Bowel Syndrome (PTB_IBS)
- Fit questions
- Built from NCT06720805, who can take part
- Record updated
- 6 December 2024