Clinical Trial: Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title:

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 Summary:
Sponsor: Eyal Kedar

Current Primary Outcome: Weighted and unweighted UniFrac distances between stool samples from the five study groups [ Time Frame: Within 1 month of baseline visit ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Lawrence Health System

Dates:
Date Received: November 8, 2016
Date Started: October 2016
Date Completion: October 2017
Last Updated: November 9, 2016
Last Verified: November 2016