Mayo Clinic IBD Biobank

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03756649

Collaborator

(none)

1,000

Enrollment

Location

565

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Mayo Clinic IBD Biobank

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2065

Anticipated Study Completion Date :

Dec 1, 2065

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Study Participants [50 years]
Total number of participants in the study

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Konstantinos N. Lazaridis, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Konstantinos N. Lazaridis, M.D., Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03756649

Other Study ID Numbers:

18-007941

First Posted:

Nov 28, 2018

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Konstantinos N. Lazaridis, M.D., Principal Investigator, Mayo Clinic

IBD

Ulcerative colitis

Crohn's

Additional relevant MeSH terms:

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Feb 24, 2022