Inflammatory Bowel DiseasesNCT03756649
Mayo Clinic IBD Biobank
An observational study of Inflammatory Bowel Diseases, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Blood Draw, Urine Collection and Stool Collection
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to Dec 2065
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with known liver disease.
- Patients unable to provide informed consent.
- Prisoners and institutionalized individuals.
- Patients with a history of colorectal cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.
Read the 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).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Blood Draw, Urine Collection, Stool Collection
- Keywords
- IBD, Ulcerative colitis, Crohn's
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
50 ml will be collected
Urine CollectionProcedure or surgery
50 ml will be collected
Stool CollectionProcedure or surgery
Three 25 ml tubes will be collected
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool Receives: Procedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool Collection | |
| Inflammatory bowel disease (IBD) | Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool Receives: Procedure: Blood Draw; Procedure: Urine Collection; Procedure: Stool Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Participants
Total number of participants in the study
Measured: 50 years
Secondary outcomes (3)
Urine Collection
Total number of urine samples collected
Measured: 50 years
Blood Collection
Total number of blood samples collected
Measured: 50 years
Stool Collection
Total number of stool samples collected
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Nov 2018
- Primary completionDec 2065 (estimated)
- Study completionDec 2065 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos N. Lazaridis, M.D., Mayo Clinic
- Investigators
- Konstantinos N. Lazaridis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756649
- Sponsor's protocol ID
- 18-007941
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic IBD Biobank
- ClinicalTrials.gov ID
- NCT03756649
- Acronym / sponsor ID
- 18-007941
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, Ulcerative colitis, Crohn's
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Dec 2065 (estimated)
- Study completion
- Dec 2065 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Procedure: 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with known liver disease.
- Patients unable to provide informed consent.
- Prisoners and institutionalized individuals.
- Patients with a history of colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Draw50 ml will be collected | Procedure or surgery | Control Group, Inflammatory bowel disease (IBD) |
| Urine Collection50 ml will be collected | Procedure or surgery | Control Group, Inflammatory bowel disease (IBD) |
| Stool CollectionThree 25 ml tubes will be collected | Procedure or surgery | Control Group, Inflammatory bowel disease (IBD) |
Primary outcome
Study Participants
Time frame: 50 years
Total number of participants in the study
3 secondary outcomes
Urine Collection
Time frame: 50 years
Blood Collection
Time frame: 50 years
Stool Collection
Time frame: 50 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konstantinos N. Lazaridis, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Participants (time frame: 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.