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Mayo Clinic IBD Biobank

NCT03756649 — Enrolling by invitation, 1000 participants, Mayo Clinic

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RegistryNCT03756649
StatusEnrolling by invitation
Study typeObservational
Enrollment1000 (Estimated)
SponsorMayo Clinic (Other)
ConditionsInflammatory Bowel Diseases
InterventionsBlood Draw, Urine Collection, Stool Collection (Procedure)
Datesstart 2018-11-01, primary completion 2065-12-01 (estimated), completion 2065-12-01 (estimated), first posted 2018-11-28, last updated 2026-02-17
Locations1 site in United States

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-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Control GroupProcedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool CollectionSubjects 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 CollectionSubjects with known inflammatory bowel disease will have samples collected of blood, urine and stool
  • Blood Draw (Procedure): 50 ml will be collected
  • Urine Collection (Procedure): 50 ml will be collected
  • Stool Collection (Procedure): Three 25 ml tubes will be collected

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • 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

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.

+Locations (1)

FacilityCityCountryStatus
Mayo ClinicRochester, MinnesotaUnited States

+Investigators

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