Clinical trial NCT02389075: The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
Official title: The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Diseases (IBD)
Ankylosing Spondylitis (AS)
Keywords: intraepithelial lymphocytes (IEL)
microbiome
colon mucosa
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2015-03-17
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inflammatory Bowel Disease, Ankylosing Spondylitis, and Healthy Controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: IEL characteristics in IBD, AS, and healthy controls
timeFrame: 1 hour after colonoscopy
Secondary outcomes:
measure: Microbiome Differences in IBD, AS, and healthy controls
timeFrame: 1 hour after colonoscopy
measure: Microbiome changes are reflected in IELs
timeFrame: 1 hour after colonoscopy
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kristie Kuhn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.