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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT03261206
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of CD at least 3 months prior to enrollment
* Taking any brand or dosage of an oral aminosalicylate for at least 6 months
* Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
* CD currently in clinical remission
* Able to participate fully in all aspects of the clinical trial
* Written informed consent obtained and documented
Exclusion Criteria:
* A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
* A diagnosis of short-bowel syndrome
* Active perianal disease
* Active fistulizing disease
* A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
* Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
* Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
* Unwillingness to stop taking aminosalicylates for the duration of the trial
* Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
* Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
* History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
* Currently participating in another interventional trial, or previous participation within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03261206
Study Brief:
Protocol Section:
NCT03261206