| Registry | NCT03756649 |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 1000 (Estimated) |
| Sponsor | Mayo Clinic (Other) |
| Conditions | Inflammatory Bowel Diseases |
| Interventions | Blood Draw, Urine Collection, Stool Collection (Procedure) |
| Dates | start 2018-11-01, primary completion 2065-12-01 (estimated), completion 2065-12-01 (estimated), first posted 2018-11-28, last updated 2026-02-17 |
| Locations | 1 site in United States |
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Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.
Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment. Following the informed consent process, subjects will provide a blood sample (50 ml), urine sample (50 ml), and stool. The blood and urine samples will either be collected at the one of the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to complete a questionnaire and 24-hour food recall questionnaire (completed online).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group | Procedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool Collection | Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool | |
| Inflammatory bowel disease (IBD) | Procedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool Collection | Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool |
Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers
Inclusion Criteria: * Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and 85 at time of study enrollment. * The diagnosis of IBD will be based on the standard IBD criteria including biochemical and colonoscopy screening. * Women with inflammatory bowel disease of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. * Patients between the ages of 18 and 85 without history of IBD or colon cancer. Exclusion Criteria: * Patients with known liver disease. * Patients unable to provide informed consent. * Prisoners and institutionalized individuals. * Patients with a history of colorectal cancer.
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic | Rochester, Minnesota | United States |