Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT06720805
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT06720805
Study Brief:
Protocol Section:
NCT06720805