Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02962479

Enrollment

Registered

2016-11-11

Start date

2016-10-31

Completion date

2017-10-31

Last updated

2016-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Axial Spondyloarthritis

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Able to provide informed consent * Male or Female patients ≥18 years of age * Additional Inclusion Criteria based on cohort

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) * Additional

Design outcomes

Primary

Measure	Time frame
Weighted and unweighted UniFrac distances between stool samples from the five study groups	Within 1 month of baseline visit

Countries

United States

Outcome results