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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT05663060
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥18 years
* Diagnosis of IBS according to Rome IV criteria
* Mild to moderate disease, as measured by FBDSI
* Absence of signs and symptoms that may suggest organic damage and, if indicated, negative instrumental investigations (colonoscopy and/or imaging)
* Prescription of Bifidice, according to normal clinical practice
* Informed consent expressed in written form
Exclusion Criteria:
* Patients undergoing surgical resection of the stomach, gallbladder, small or large intestine
* History of inflammatory bowel disease
* Severe SII, measured by FBDSI
* Active peptic ulcer
* History of ischemic colitis
* Active infectious enteritis
* Diagnosed with hypo- or hyperthyroidism
* Need for pharmacological treatments for IBS, antibiotics, antidepressants and laxatives
* Therapy in progress with drug or supplements included in the list of those not allowed (Paragraph N: to be established)
* Any disease that may affect gastrointestinal function and could interfere with appropriate assessment of abdominal pain or discomfort
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05663060
Study Brief:
Protocol Section:
NCT05663060