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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT06810518
Eligibility Criteria:
Inclusion criteria:
* Male or female, ≥22 years of age (adults)
* Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
* Able to provide a sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.
* Able to understand the study and the tasks required and sign the ICF
Exclusion criteria:
* Unable or unwilling to provide a stool specimen
* Known active intestinal cancer or in remission with abnormal levels (per physician assessment)
* Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)
* IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
* IBD patients who have previously diagnosed IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA
* IBD patients who have previously been diagnosed with IBD and have undergone a surgical resection or diversion procedure.
* Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease
* Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample
* Samples are not collected according to sampling protocol.
* Any condition that in the opinion of the investigator should preclude participation in the study.
Using an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06810518
Study Brief:
Protocol Section:
NCT06810518