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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT03078803
Eligibility Criteria:
Inclusion Criteria:
* mild to moderate ileal, ileo-colonic or colonic Crohns disease
* active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein \>8mg/L, elevated fecal calprotectin \>250 ug/g
* If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
* Use of effective contraception
Exclusion Criteria:
* Antibiotic exposure within 30 days and probiotic exposure within 14 days
* topical inflammatory bowel disease therapy within 2 weeks
* active perianal disease
* requirement for concurrent antibiotic therapy
* SES-CD score \<5
* severe CD HBI \>25 or need for hospitalization
* abdominal abscess
* extensive colonic resection, subtotal or total colectomy
* ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
* evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
* requiring or expected to require surgical intervention
* history or evidence of adenomatous colonic polyps not removed
* history of evidence of colonic dysplasia
* active substance abuse or psychiatric problems that may interfere with study
* chronic Hep B, C, or HIV infection
* pregnancy or planning to become pregnant
* upper CD
* history of adhesions preventing colonoscopy to cecum
* planned bowel resection within 3 mon of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03078803
Study Brief:
Protocol Section:
NCT03078803