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:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT02193750
Eligibility Criteria:
Inclusion Criteria:
* age \>/= 19 years
* diagnosed with CD for \>/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (\</= 4 points) and C-reactive protein (\<5mg/L)
Exclusion Criteria:
* unable to provide informed consent;
* have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular disease;
* confirmed diagnosis of celiac disease, or have suspected celiac disease and are following a gluten-free diet to manage symptoms with an elevated screening anti-tissue transglutaminase antibody test;
* significant complications of CD which includes a history of extensive colonic resection, including subtotal or total colectomy, history of \>/= 3 small bowel resections or received a diagnosis of short bowel syndrome, current ileostomy, colostomy or ileal-anal pouch, or a fixed symptomatic intestinal stenosis;
* antibiotic use in the 4 weeks prior to study start;
* use of any rectal preparations in the 2 weeks prior to study start;
* use of any non-steroidal anti-inflammatory drugs in the 2 weeks prior to study start;
* use of commercial probiotic supplements in the 4 weeks prior to study start
* change in CD therapy in the 4 weeks prior to study start (excluding steroid taper, however steroid dosing must be stable for 2 weeks prior to study start);
* recently been adhering to a novel dietary intervention for alternative health issues within the last 4 weeks prior to study start.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02193750
Study Brief:
Protocol Section:
NCT02193750