NCT03756649

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
480mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Nov 2018Dec 2065

Study Start

First participant enrolled

November 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
47 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2065

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2065

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

47.1 years

First QC Date

November 27, 2018

Last Update Submit

February 12, 2026

Conditions

Inflammatory Bowel Diseases

Keywords

IBDUlcerative colitisCrohn's

Outcome Measures

Primary Outcomes (1)

  • Study Participants

    Total number of participants in the study

    50 years

Secondary Outcomes (3)

  • Urine Collection

    50 years

  • Blood Collection

    50 years

  • Stool Collection

    50 years

Study Arms (2)

Control Group

Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool

Procedure: Blood DrawProcedure: Urine CollectionProcedure: Stool Collection

Inflammatory bowel disease (IBD)

Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool

Procedure: Blood DrawProcedure: Urine CollectionProcedure: Stool Collection

Interventions

Blood DrawPROCEDURE

50 ml will be collected

Control GroupInflammatory bowel disease (IBD)
Urine CollectionPROCEDURE

50 ml will be collected

Control GroupInflammatory bowel disease (IBD)
Stool CollectionPROCEDURE

Three 25 ml tubes will be collected

Control GroupInflammatory bowel disease (IBD)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with known liver disease.
  • Patients unable to provide informed consent.
  • Prisoners and institutionalized individuals.
  • Patients with a history of colorectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood work to be obtained from patient to be processed and stored until needed in the future for potential research.

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, Ulcerative

Interventions

Blood Specimen CollectionUrine Specimen Collection

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Konstantinos N. Lazaridis, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 28, 2018

Study Start

November 1, 2018

Primary Completion (Estimated)

December 1, 2065

Study Completion (Estimated)

December 1, 2065

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(1)