Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

Eyal Kedar

Status: Unknown

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis

Study type: Observational

Funder types: Other

Identifiers

NCT02962479

EK001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 Exclusion Criteria based on cohort

Trial design

50 participants in 5 patient groups

TNF blocker-naïve ankylosing spondylitis patients

TNF blocker-exposed ankylosing spondylitis patients

TNF blocker-naïve nrSpA patients

TNF blocker-exposed nrSpA patients

Healthy Participants