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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03953794
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Able to provide written informed consent prior to screening and willing to comply with the requirements of the study protocol
* Have had a diagnosis of ulcerative colitis or Crohn's Disease confirmed by a clinician
* Have had quiescent disease for the past 3 months or longer as determined by clinician
* Have had most recent episode of disease within past 24 months as determined by clinician
* Have had stable IBD medication (other than antibiotics) regimen for the past 3 months or longer
* Able to speak and read English sufficiently
* Be able and comfortable using new technology: the app and the smartwatch for 12 months
Exclusion Criteria:
* If female, is pregnant or is breast feeding, or intends to become pregnant within the 12 month study period
* Unable to provide informed consent or unwilling to participate
* Use of oral or intravenous antibiotics within 4 weeks prior to screening
* Current use of glucocorticoid steroid, or nonsteroidal anti-inflammatory drugs (NSAIDs) within the last 3 months
* Evidence of untreated infection e.g. Clostridium difficile
* Confirmed diagnosis of extraintestinal manifestations (EIMs) of disease including those that occur concurrent with colitis (episcleritis, scleritis, uveitis, peripheral arthropathies of small and large joints, dermatologic conditions such as erythema nodosum and pyoderma gangrenosum), and those that occur independent of colitis (sacroilitis, ankylosing spondylitis, or primary sclerosing cholangitis)
* Confirmed diagnosis of other serious disease unrelated to ulcerative colitis or Crohn's Disease
* Current smoker
* Unable to speak or read English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03953794
Study Brief:
Protocol Section:
NCT03953794