Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

Ankylosing Spondylitis Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02962479
• Other study ID #: EK001
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 9, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: St. Lawrence Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
United States	St. Lawrence Health System	Potsdam	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eyal Kedar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weighted and unweighted UniFrac distances between stool samples from the five study groups		Within 1 month of baseline visit	No