The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

NCT ID: NCT02389075

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2026-10-31

Brief 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.

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.

Conditions

Inflammatory Bowel Diseases (IBD); Ankylosing Spondylitis (AS)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Pinch biopsies

Intervention Type: PROCEDURE

Biopsies obtained during colonoscopy or flexible sigmoidoscopy.

Flexible sigmoidoscopy

Intervention Type: PROCEDURE

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.

Pinch biopsies

Intervention Type: PROCEDURE

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.

Pinch biopsies

Intervention Type: PROCEDURE

Biopsies obtained during colonoscopy or flexible sigmoidoscopy.

Interventions

Pinch biopsies

Biopsies obtained during colonoscopy or flexible sigmoidoscopy.

Intervention Type: PROCEDURE

Flexible sigmoidoscopy

Offered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristie Kuhn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30029674 (View on PubMed)

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1507

Identifier Type: -

Identifier Source: org_study_id