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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02423460
Eligibility Criteria:
Inclusion Criteria (healthy controls):
* Male age 18 - 40 years of age
* Having obtained his (or his legal representative's) written informed consent.
* Normally nourished and without any inter-current illness.
* Absence of an active inflammatory process in the past month.
Exclusion Criteria (healthy controls):
* Subject who cannot be expected to comply with the study procedures.
* Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
Inclusion Criteria: Crohn's Disease and Ulcerative Colitis
* Male age 18 - 40 years of age
* Having obtained his (or his legal representative's) Written Informed Consent.
* For both conditions, stable disease state and not malnourished per the treating physician.
* CD: Harvey Bradshaw Index (HBI) ≤ 8, disease location: evidence of ileal and or colon inflammatory involvement, no known strictures
* UC: Mayo Score ≤ 7 (or Partial Mayo Score ≤5)
* No tube feeding - Subjects must be treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto.
Exclusion Criteria: Crohn's Disease and Ulcerative Colitis
* Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
* Concomitant treatment:corticosteroids \> 20mg/day
* Subject who cannot be expected to comply with the study procedures. - Subjects not treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02423460
Study Brief:
Protocol Section:
NCT02423460