Mayo Clinic IBD Biobank

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Procedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool Collection

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool	Procedure: Blood Draw; 50 ml will be collected; Procedure: Urine Collection; 50 ml will be collected; Procedure: Stool Collection; Three 25 ml tubes will be collected
Inflammatory bowel disease (IBD); Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool	Procedure: Blood Draw; 50 ml will be collected; Procedure: Urine Collection; 50 ml will be collected; Procedure: Stool Collection; Three 25 ml tubes will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Participants	Total number of participants in the study	50 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Collection	Total number of urine samples collected	50 years
Blood Collection	Total number of blood samples collected	50 years
Stool Collection	Total number of stool samples collected	50 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Konstantinos N. Lazaridis, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Estimated): December 1, 2065
• Study Completion (Estimated): December 1, 2065

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: IBD; Ulcerative colitis; Crohn's
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 18-007941

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No