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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT03269032
Eligibility Criteria:
Inclusion Criteria:
* must be willing to eat pre-prepared foods for 4 weeks
* subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet.
* Phase 2 subjects- must have diagnosis of IBS based on Rome III criteria and have diarrhea-predominant disease, defined as \>50% of bowel movements characterized as diarrhea
Exclusion Criteria:
* history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance
* diabetes mellitus
* congestive heart failure
* coronary artery disease
* chronic liver disease or end stage renal disease
* pregnancy or breastfeeding
* trainees under the direct supervision of the PI and patients receiving direct ongoing medical care from the PI or Co-I will not be enrolled as subjects in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03269032
Study Brief:
Protocol Section:
NCT03269032