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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04809194
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Crohn's disease previously established by endoscopy, imaging, and/or histology
* Disease of the small bowel, large bowel, or both large and small bowel
* Needs to have at least one flare in the last 12 months while on current therapy
* Subjects may be on no treatment or may have concurrent treatment with 5-aminosalicylates, antibiotics, corticosteroids, thiopurines, methotrexate or biologic therapies, including infliximab, adalimumab, certolizumab pegol, vedolizumab, or ustekinumab
* Disease level, see stratified enrollment below
* Subjects must have a personal cell phone that is an iPhone SE or newer and be willing to upgrade to the most recent iOS operating system and use their phone for study. This includes a willingness to download and use the study applications and sync their phone with the necessary study devices.
Exclusion Criteria:
* Imminent indication for surgery, such as small bowel obstruction or abscess, or surgery in the past 4 weeks
* More than 100 cm of small bowel resected
* Dependence on chronic enteral supplementation or parenteral nutrition or fluids
* Ileostomy or Colostomy (some of the outcome measures do not apply as cannot count # bowel movements)
* History of asymptomatic Crohn's disease for the last 2 years
* Current use of investigational therapy
* Self-reported pregnancy or intent to become pregnant during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04809194
Study Brief:
Protocol Section:
NCT04809194