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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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 dificile within the past 3 months - A known history of idiopathic macroscopic or microscopic colitis

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02389075
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Colorado, Denver
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kristie Kuhn, MD, PhD
Principal Investigator Affiliation University of Colorado, Denver
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Inflammatory Bowel Diseases (IBD), Ankylosing Spondylitis (AS)
Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

: 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Denver, Colorado

Status

Address

Denver, Colorado,

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