The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
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ClinicalTrials.gov Identifier: NCT02389075 |
Recruitment Status :
Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : October 28, 2021
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Condition or disease | Intervention/treatment |
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Inflammatory Bowel Diseases (IBD) Ankylosing Spondylitis (AS) | Procedure: Pinch biopsies Procedure: Flexible sigmoidoscopy |
Study Type : | Observational |
Actual Enrollment : | 129 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | October 2025 |

Group/Cohort | Intervention/treatment |
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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.
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Procedure: Pinch biopsies
Biopsies obtained during colonoscopy or flexible sigmoidoscopy. Procedure: Flexible sigmoidoscopy Offered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy |
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.
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Procedure: Pinch biopsies
Biopsies obtained during colonoscopy or flexible sigmoidoscopy. |
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.
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Procedure: Pinch biopsies
Biopsies obtained during colonoscopy or flexible sigmoidoscopy. |
- 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.
- Microbiome Differences in IBD, AS, and healthy controls [ Time Frame: 1 hour after colonoscopy ]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.
- Microbiome changes are reflected in IELs [ Time Frame: 1 hour after colonoscopy ]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).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Healthy Controls
Exclusion criteria:
- 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
IBD
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
Inclusion Criteria:
- Diagnosed with an axial spondyloarthritis (SpA) by a rheumatologist -
- Meet the Assessment of SpondyloArthritis international Society (ASAS) axial spondyloarthritis (SpA) criteria
Exclusion criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389075
United States, Colorado | |
Denver, Colorado, United States |
Principal Investigator: | Kristie Kuhn, MD, PhD | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02389075 |
Other Study ID Numbers: |
14-1507 UL1TR001082 ( U.S. NIH Grant/Contract ) |
First Posted: | March 17, 2015 Key Record Dates |
Last Update Posted: | October 28, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
intraepithelial lymphocytes (IEL) microbiome colon mucosa |
Spondylitis Spondylitis, Ankylosing Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Bone Diseases, Infectious Infections |
Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis |