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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT03051204
Eligibility Criteria:
Inclusion Criteria:
* Male and female IBD patients should have had CD or UC for at least a period of six months\*
* Male and female patients should have had Celiac disease for at least three months.
* Subjects willing and able to sign informed consent
* Subjects willing and able to provide stool sample using a home kit
* IBS patients will meet Rome Foundation criteria and received standard of care evaluations to exclude other diagnoses
* Healthy controls will consist of patients who do not have any IBD or IBS diagnosis and meet exclusion criteria for health in nearby table
Exclusion Criteria:
* Unwilling or unable to adhere to the protocol
* Unwilling or unable to adhere to the informed consent
* Age \<4y or \>65y
* Any of the following conditions by medical history:
* Individuals with intestinal cancer
* Individual taking anti-inflammatory drugs
* Individuals receiving chemotherapy
* Individuals with a known intestinal infection
* Individuals with known upper gastrointestinal disease such as esophagitis or gastritis that might influence the test's ability to detect intestinal inflammatory disease.
* Individuals who are scheduled for endoscopy within 24 hours after providing the sample, or have undergone endoscopy during the 72 hours before providing the sample.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
65 Years
Study:
NCT03051204
Study Brief:
Protocol Section:
NCT03051204