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

NCT02389075 | Active Not Recruiting

• 2 other identifiers: 14-1507UL1TR001082
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

intraepithelial lymphocytes (IEL); microbiome; colon mucosa

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour after colonoscopy

Secondary Outcomes (2)

• Microbiome Differences in IBD, AS, and healthy controls

  1 hour after colonoscopy

• Microbiome changes are reflected in IELs

  1 hour after colonoscopy

Study Arms (3)

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.

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.

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.

Procedure: Pinch biopsies

Interventions

Pinch biopsies PROCEDURE

Biopsies obtained during colonoscopy or flexible sigmoidoscopy.

Ankylosing Spondylitis; Healthy Controls; Inflammatory Bowel Disease

Flexible sigmoidoscopy PROCEDURE

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

Ankylosing Spondylitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inflammatory Bowel Disease, Ankylosing Spondylitis, and Healthy Controls

You may not qualify if:

• 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
• 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.
• Pregnancy
• Use of antibiotics within the past 14 days

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Colorado

Denver, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 30029674 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Colon pinch biopsies, white blood cells.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Kristie Kuhn, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)