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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02227602
Eligibility Criteria:
Inclusion Criteria:
* Male or female ages 18-79 years (see Protection of Human Subjects)
* Treated with mesalamine or any mesalamine derivate, e.g.Asacol, Apriso, Asacol, Canasa, Lialda, Pentasa, Rowasa orally or rectally as standard of clinical care in the treatment of their symptoms for Inflammatory bowel disease
* Treated using biologic immune-modulators including but not limited to: Infliximab, Adalimumab, Certolizumab, Natalizumab, azathioprine.
* Additionally, patients may be on steroids (prednisone 10mg, budesonide 9mg)
* Subjects must have been on a stable drug-regiment for at least 3 weeks before study begin.
Exclusion Criteria:
* history of acute cardiac event, stroke, or cancer, within the last 6 months,
* recurrent hospitalizations,
* drug treatment of any of the listed conditions within the last 6 months,
* abuse of alcohol or substance within the last 6 months,
* currently smoking more than 1 pack/week,
* seizures,
* liver or renal dysfunction,
* pregnancy or lactation,
* allergy against mangos,
* hepatitis B, C, or HIV,
* regular exercise (\>60 minutes, ≥ 5 times/wk), due to association of antioxidant and anti-inflammatory effects and moderate exercise.
* known lactose intolerance, gluten sensitivity, or celiac disease
* Patients that have upcoming Inflammatory bowel disease-related surgery and Inflammatory bowel disease -related intestinal stricture will also be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT02227602
Study Brief:
Protocol Section:
NCT02227602