Inflammatory Bowel Diseases (IBD)NCT02389075
The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
An observational study of Inflammatory Bowel Diseases (IBD) and Ankylosing Spondylitis (AS), run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the relationship between systemic autoimmune disease, such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon, and the changes in colon tissue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases (IBD), Ankylosing Spondylitis (AS)
- What is being tested?
- Pinch biopsies and Flexible sigmoidoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inflammatory Bowel Disease, Ankylosing Spondylitis, and Healthy Controls
Who may be able to join
- Established IBD (either Crohn's disease or ulcerative colitis)
- Suspected to have IBD by a gastroenterologist and undergoing diagnostic endoscopy and biopsy. Diagnosis will be confirmed on biopsy and patients who are negative will be considered for controls based on the pathology found.
- Diagnosed with an axial spondyloarthritis (SpA) by a rheumatologist -
- Meet the Assessment of SpondyloArthritis international Society (ASAS) axial spondyloarthritis (SpA) criteria
Who cannot join
- Pregnancy
- Use of antibiotics within the past 14 days†
- Current diagnosis of colon cancer
- Diagnosis of celiac disease
- Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
- Chemotherapy or radiation therapy for any malignancy within the past year
Show all 34Show fewer
- Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
- Current use of anticoagulation (LMWH,warfarin,etc.)
- A diagnosis of HIV
- Clostridium difficile within the past 3 months
- IBD
- Pregnancy
- Use of antibiotics within the past 14 days
- Current diagnosis of colon cancer
- Diagnosis of celiac disease
- Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
- Chemotherapy or radiation therapy for any malignancy within the past year
- Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
- Current use of anticoagulation (LMWH, warfarin,etc.)
- A diagnosis of HIV
- Clostridium difficile within the past 3 months
- Evidence of inflammatory spinal or axial arthritis or disease based on chart review such as inflammation seen on radiographs or a diagnosis of sacroiliitis
- AS:
- Pregnancy
- Use of antibiotics within the past 14 days
- Current diagnosis of colon cancer
- Diagnosis of celiac disease
- Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
- Chemotherapy or radiation therapy for any malignancy within the past year
- Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
- Current use of anticoagulation (LMWH,warfarin,etc.)
- A diagnosis of HIV
- Clostridium difficile within the past 3 months
- A known history of idiopathic macroscopic or microscopic colitis
Trial locations and contacts
1 site in 1 country.
About this study
This study plans to learn more about the relationship between systemic autoimmune disease, such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon, and the changes in colon tissue.
Read the detailed description
Changes in human gut bacteria has been shown in patients with autoimmune diseases, such as inflammatory bowel diseases (IBD). The gut flora in ankylosing spondylitis (AS), an arthritis that can occur with IBD, has not been well studied. The immune cells in the colon directly interface with bacteria and may be influenced by them. The interactions between the colon immune system, bacteria and autoimmunity hasn't been studied. The study goal is to specifically study the link between bacteria, the colonic immune system, and the autoimmune diseases of AS and IBD. This will be done by collecting clinical data by questionnaires, blood samples, colonic tissue during endoscopy, and microbiome data in subjects with IBD, AS, and controls.
- Being tested
- Pinch biopsies, Flexible sigmoidoscopy
- Keywords
- intraepithelial lymphocytes (IEL), microbiome, colon mucosa
- Medical subject headings
- Inflammatory Bowel Diseases, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinch biopsiesProcedure or surgery
Biopsies obtained during colonoscopy or flexible sigmoidoscopy.
Flexible sigmoidoscopyProcedure or surgery
Offered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis | Subjects with a diagnosis of ankylosing spondylitis undergoing routine colonoscopy or willing to undergo a flexible sigmoidoscopy for research purposes only. They will be asked to fill out questionnaires, give blood, perform a rectal swab, and have pinch biopsies taken during endoscopy. Receives: Procedure: Pinch biopsies; Procedure: Flexible sigmoidoscopy | |
| Inflammatory Bowel Disease | Subjects with a diagnosis of inflammatory bowel disease undergoing routine colonoscopy. They will be asked to fill out questionnaires, give blood, perform a rectal swab, and have pinch biopsies taken during endoscopy. Receives: Procedure: Pinch biopsies | |
| Healthy Controls | Subjects without any major autoimmune diseases or pathologies undergoing routine colonoscopy. They will be asked to fill out questionnaires, give blood, perform a rectal swab, and have pinch biopsies taken during endoscopy. Receives: Procedure: Pinch biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
IEL characteristics in IBD, AS, and healthy controls
The primary goal for this measure will be to demonstrate characteristics of IEL (intraepithelial lymphocytes) subtypes of healthy individuals and compare those with AS or IBD. IEL characteristics will be based on cell marker outcomes using flow cytometry for CD3, CD4, CD8α, CD8β, CD44, CD45, CD62L, CD69, CD103, TCRαβ, and TCRγδ.
Measured: 1 hour after colonoscopy
Secondary outcomes (2)
Microbiome Differences in IBD, AS, and healthy controls
The primary hypothesis is that the microbiome population will differ between controls, IBD, and AS; outcomes for this hypothesis will include relative abundance (RA) of individual bacterial species and the Shannon Index for community diversity.
Measured: 1 hour after colonoscopy
Microbiome changes are reflected in IELs
The primary hypothesis is that dysbiosis will be reflected in the IEL populations in AS and IBD by having a different predominant phenotype (as seen by cell markers) compared to healthy controls; the investigators will evaluate the IEL outcomes determined to be significantly different among AS, IBD, and healthy controls as identified in Outcome 1 (Primary Outcome).
Measured: 1 hour after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Diseases (IBD)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Kristie Kuhn, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389075
- Sponsor's protocol ID
- 14-1507
- Other IDs
- UL1TR001082
- Status last verified
- May 2024
- First submitted
- 9 Mar 2015
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Regner EH, Ohri N, Stahly A, Gerich ME, Fennimore BP, Ir D, Jubair WK, Gorg C, Siebert J, Robertson CE, Caplan L, Frank DN, Kuhn KA. Functional intraepithelial lymphocyte changes in inflammatory bowel disease and spondyloarthritis have disease specific correlations with intestinal microbiota. Arthritis Res Ther. 2018 Jul 20;20(1):149. doi: 10.1186/s13075-018-1639-3.
PubMed 30029674
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02389075
- Acronym / sponsor ID
- 14-1507
- Keywords
- intraepithelial lymphocytes (IEL), microbiome, colon mucosa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Mar 2015
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- 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.
This study plans to learn more about the relationship between systemic autoimmune disease, such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon, and the changes in colon tissue.
Detailed description
Changes in human gut bacteria has been shown in patients with autoimmune diseases, such as inflammatory bowel diseases (IBD). The gut flora in ankylosing spondylitis (AS), an arthritis that can occur with IBD, has not been well studied. The immune cells in the colon directly interface with bacteria and may be influenced by them. The interactions between the colon immune system, bacteria and autoimmunity hasn't been studied. The study goal is to specifically study the link between bacteria, the colonic immune system, and the autoimmune diseases of AS and IBD. This will be done by collecting clinical data by questionnaires, blood samples, colonic tissue during endoscopy, and microbiome data in subjects with IBD, AS, and controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis | – | Procedure: Pinch biopsies, Procedure: Flexible sigmoidoscopySubjects with a diagnosis of ankylosing spondylitis undergoing routine colonoscopy or willing to undergo a flexible sigmoidoscopy for research purposes only. They will be asked to fill out questionnaires, give blood, perform a rectal swab, and have pinch biopsies taken during endoscopy. |
| Inflammatory Bowel Disease | – | Procedure: Pinch biopsiesSubjects with a diagnosis of inflammatory bowel disease undergoing routine colonoscopy. They will be asked to fill out questionnaires, give blood, perform a rectal swab, and have pinch biopsies taken during endoscopy. |
| Healthy Controls | – | Procedure: Pinch biopsiesSubjects without any major autoimmune diseases or pathologies undergoing routine colonoscopy. They will be asked to fill out questionnaires, give blood, perform a rectal swab, and have pinch biopsies taken during endoscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inflammatory Bowel Disease, Ankylosing Spondylitis, and Healthy Controls
Key inclusion criteria (4 listed)
- Established IBD (either Crohn's disease or ulcerative colitis)
- Suspected to have IBD by a gastroenterologist and undergoing diagnostic endoscopy and biopsy. Diagnosis will be confirmed on biopsy and patients who are negative will be considered for controls based on the pathology found.
- Diagnosed with an axial spondyloarthritis (SpA) by a rheumatologist -
- Meet the Assessment of SpondyloArthritis international Society (ASAS) axial spondyloarthritis (SpA) criteria
Key exclusion criteria (34 listed)
- Pregnancy
- Use of antibiotics within the past 14 days†
- Current diagnosis of colon cancer
- Diagnosis of celiac disease
- Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
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 |
|---|---|---|
| Pinch biopsiesBiopsies obtained during colonoscopy or flexible sigmoidoscopy. | Procedure or surgery | Ankylosing Spondylitis, Healthy Controls, Inflammatory Bowel Disease |
| Flexible sigmoidoscopyOffered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy | Procedure or surgery | Ankylosing Spondylitis |
Primary outcome
IEL characteristics in IBD, AS, and healthy controls
Time frame: 1 hour after colonoscopy
The primary goal for this measure will be to demonstrate characteristics of IEL (intraepithelial lymphocytes) subtypes of healthy individuals and compare those with AS or IBD. IEL characteristics will be based on cell marker outcomes using flow cytometry for CD3, CD4, CD8α, CD8β, CD44, CD45, CD62L, CD69, CD103, TCRαβ, and TCRγδ.
2 secondary outcomes
Microbiome Differences in IBD, AS, and healthy controls
Time frame: 1 hour after colonoscopy
Microbiome changes are reflected in IELs
Time frame: 1 hour after colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 30029674Regner EH, Ohri N, Stahly A, Gerich ME, Fennimore BP, Ir D, Jubair WK, Gorg C, Siebert J, Robertson CE, Caplan L, Frank DN, Kuhn KA. Functional intraepithelial lymphocyte changes in inflammatory bowel disease and spondyloarthritis have disease specific correlations with intestinal microbiota. Arthritis Res Ther. 2018 Jul 20;20(1):149. doi: 10.1186/s13075-018-1639-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kristie Kuhn, MD, PhD principal investigator
University of Colorado, Denver
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 (IBD) and Ankylosing Spondylitis (AS), run by University of Colorado, Denver 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 34 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
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?
IEL characteristics in IBD, AS, and healthy controls (time frame: 1 hour after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389075, which also lists 1 linked publication.
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 21 May 2024.