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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02355834
Eligibility Criteria:
For active case-finding: diagnosis of IBD,between 18 and 80 years of age; diagnosis of IBD confirmed with endoscopy / colonoscopy; no stoma.
For RCT and patient interviews: Patients with IBD who experience FI, are interested in interventions, and meet the following:
Inclusion criteria:
* Endoscopically confirmed IBD diagnosis
* Between 18 and 80 years of age
* No current flare-up of disease (self-report of usual symptoms when not in active flare)
* Reporting FI at least once in the past year
* With or without ileo-anal pouch plus:
Exclusion criteria:
* Under 18 or over 80
* Current disease flare-up (self-report of usual symptoms indicative of active flare)
* Course of specialist FI treatment in past year
* Previous major anal fistula surgery (surgical lay-open) or current perianal fistula
* Current stoma
* Current participation in another trial
* Inability to give informed consent (for example, due to reduced mental capacity)
* Inability to read or speak sufficient English to understand study documents, procedures and requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02355834
Study Brief:
Protocol Section:
NCT02355834