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Enrolling by invitation NCT03756649

Mayo Clinic IBD Biobank

Observational Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Draw, Urine Collection, Stool Collection.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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

Primary outcome measures

  • Study Participants [Time frame: 50 years]
Secondary outcome measures (3)
  • Urine Collection [Time frame: 50 years]
  • Blood Collection [Time frame: 50 years]
  • Stool Collection [Time frame: 50 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT03756649 · 18-007941

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗