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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT03537157
Eligibility Criteria:
Inclusion Criteria:
* Crohn Disease with curative ileocolonic resection
* Randomization within 45 days from ileocolonic resection or end or loop ileostomy within last year and closure occurred within 45 days from randomization
* Fecal stream restoration at least 14 days prior to randomization
* Presence of at least one risk factor for recurrence
* Pregnancy protection on board during the study for childbearing female subjects
Exclusion Criteria:
* Presence of CD proximally or distally to the site of resection
* Patients with strictureplasties at index surgery or ileorectal anastomosis
* patients with active perianal CD
* Patient treated with other treatments usually utilised for CD
* Patients with active diseases with gastrointestinal involvement
* intestinal obstruction or pseudo-obstruction
* Patients presenting diarrhoea plus fever or bloody stools
* Positivity to clostridium difficile toxin
* Severe hepatic or renal impairment
* Presence of severe cardiac insufficiency
* Hypersensitivity to rifamycin antimicrobial agents
* other conditions that would interfere or prevent the study completion
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03537157
Study Brief:
Protocol Section:
NCT03537157