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Pentabiocel in Pediatric IBS

Key facts

Who runs it
University of Roma La Sapienza
Where
Italy4 sites in 1 countryChoose a country to see its 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?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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