Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

• Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis

• Registration Number: NCT02962479
• Lead Sponsor: Eyal Kedar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Status Verified: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-09
• Last Update Submitted: 2016-11-09
• Study First Posted: 2016-11-11
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

St. Lawrence Health System; 🇺🇸 Potsdam, New York, United States