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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01370720
Eligibility Criteria:
Inclusion Criteria:
* IBS patients (both males and females) with positive diagnosis based on Rome III criteria (all IBS subtypes will be included)
* Age in the range 18-70 years
* Subjects capable of conforming to the study protocol
* Subjects who have given their free and informed consent
Exclusion Criteria:
* Any relevant organic, systemic or metabolic disease, such as celiac disease, IDDM (Insulin-Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapse, and urinary incontinence.
* Subjects with ascertained intestinal organic diseases (ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease).
* Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
* Previous major abdominal surgeries
* Females of childbearing potential, in the absence of effective contraceptive methods
* Subjects who become unable to conform to protocol
* Subjects who are continuously taking contact laxatives
* Subjects who have been continuously administered glucocorticoids, anti-histaminergic and mast cell stabilizer drugs within the previous 30 days
* Subjects who have been continuously administered trimebutine within the previous 30 days
* Treatment with any investigational drug within the previous 30 days
* Recent history or suspicion of alcohol abuse or drug addiction
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01370720
Study Brief:
Protocol Section:
NCT01370720