Mayo Clinic IBD Biobank

• Conditions: Inflammatory Bowel Diseases
• Interventions: Procedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool Collection

• Registration Number: NCT03756649
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.

Detailed Description

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).

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2065-12
• Study Completion: 2065-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Urine Collection	Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool
Control Group	Stool Collection	Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool
Inflammatory bowel disease (IBD)	Urine Collection	Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool
Inflammatory bowel disease (IBD)	Blood Draw	Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool
Control Group	Blood Draw	Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool
Inflammatory bowel disease (IBD)	Stool Collection	Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool

Primary Outcome Measures

Name	Time	Method
Study Participants	50 years	Total number of participants in the study

Secondary Outcome Measures

Name	Time	Method
Urine Collection	50 years	Total number of urine samples collected
Blood Collection	50 years	Total number of blood samples collected
Stool Collection	50 years	Total number of stool samples collected

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States