Pentabiocel in Pediatric IBS

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a probiotic treatment, called Pentabiocel, in children aged 4 to 17 who have Irritable Bowel Syndrome (IBS). IBS is a common condition that causes ongoing tummy pain and can lead to changes in bowel habits, such as diarrhea or constipation. The goal of the study is to see if giving children a special blend of friendly bacteria (probiotics) for 12 weeks can help improve their symptoms and overall gut health.

To participate, children must have a diagnosis of IBS and meet certain health criteria, including having no other serious health conditions or recent treatments that could interfere with the study. Participants will not be receiving any medication that could affect their IBS during the trial. This study is not yet recruiting participants, but it aims to provide valuable information about how probiotics can help young people with IBS. If you think your child might be eligible, you can keep an eye out for when the study starts recruiting.

Gender

ALL

Eligibility criteria

• 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).