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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT03378167
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients
* ≥3yo
* Crohn's disease, or IBD-Unclassified favoring Crohn's disease (as deemed by the patient's primary pediatric gastroenterologist)
* Active symptoms
Exclusion Criteria:
* Currently enrolled in another clinical trial
* Unable to give informed consent or assent
* Severe comorbid medical illness (at discretion of patient's primary pediatric gastroenterologist)
* Concomitant Clostridium difficile infection
* Severe Crohn's disease flare requiring hospitalization
* Commenced new, or temporary medical therapies (ie. corticosteroids, antibiotics, prebiotics) within 4 weeks prior to commencing the trial; NB: Weaning doses of corticosteroid will be permitted (≤ 0.25mg/kg/day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT03378167
Study Brief:
Protocol Section:
NCT03378167