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Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

NCT ID: NCT02962479

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-10-31

Brief Summary

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This study aims to compare biological communities in stool samples obtained from age, diet and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS) never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing spondylitis previously or currently treated with TNF inhibitors, subjects with non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or currently treated with TNF inhibitors and healthy participants.

The differences in fecal microbiota composition will be explored using shotgun metagenomic sequencing through the University of Washington. The investigators predict that this study will confirm a significant difference between the fecal microbiota composition (FMC) of both AS and nrSpA patients and controls.

Detailed Description

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Conditions

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Axial Spondyloarthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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TNF blocker-naïve ankylosing spondylitis patients

No interventions assigned to this group

TNF blocker-exposed ankylosing spondylitis patients

No interventions assigned to this group

TNF blocker-naïve nrSpA patients

No interventions assigned to this group

TNF blocker-exposed nrSpA patients

No interventions assigned to this group

Healthy Participants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Able to provide informed consent
* Male or Female patients ≥18 years of age

Exclusion Criteria

* Current use of any pain-relieving medications other than NSAIDs, APAP and/or opioids
* Corticosteroid therapy or probiotic exposure within the last two weeks
* Antibiotic exposure within the past two months
* History of psoriasis or inflammatory bowel disease or reactive arthritis or any other chronic rheumatologic disease
* Active infection
* History of hepatitis B or C or HIV
* Active cancer or history of colon cancer or any form of chemotherapy or radiation within the past year
* Celiac disease
* Use of proton pump inhibitors within the prior two months
* History of clostridium difficile
* Pregnancy
* Active diarrhea (defined as a decrease in fecal consistency lasting four or more weeks)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eyal Kedar

OTHER

Sponsor Role lead

Responsible Party

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Eyal Kedar

Rheumatologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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St. Lawrence Health System

Potsdam, New York, United States

Site Status

Countries

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United States

Other Identifiers

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EK001

Identifier Type: -

Identifier Source: org_study_id