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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03224494
Eligibility Criteria:
Inclusion Criteria:
1. Patients diagnosed with IBS by their treating gastroenterologist, according to the Rome IV criteria. According to Rome IV criteria, IBS is defined as:
recurrent abdominal pain, on average, at least one day per week in the last three months, associated with 2 or more of the following:
1. pain is related to defecation
2. associated with a change in stool frequency
3. associated with a change in stool form.
2. Irritable Bowel syndrome patients will be recruited from the GI motility clinic and general GI clinic at Hotel Dieu Hospital.
3. Healthy controls will be recruited from the GI clinics. These are patients coming for evaluation for non-colonic symptoms such as colon screening, gastroesophageal reflux disease, or liver disease.
Exclusion Criteria:
1. patients under the age of 18;
2. a recent change in IBS treatment regimen or patients taking analgesics, which may affect bowel sensitivity (this includes the FODMAP diet)
3. pregnant patients, as there may be a small risk of inducing labor with the barostat probe
4. patients who have had previous colorectal surgery as it may bowel sensitivity
5. healthy controls who are experiencing bowel symptoms
6. known significant anorectal pathology (eg. fistulae, abscess, stricture, etc)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03224494
Study Brief:
Protocol Section:
NCT03224494