Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

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.

Study Overview

• Status: Unknown
• Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • New York
    • Potsdam, New York, United States, 13676
      • St. Lawrence Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

At least 50 subjects, male and female, aged 18 or older, will be recruited to the study and assigned to one of five groups:

1. Ten TNF blocker-naïve ankylosing spondylitis patients
2. Ten TNF blocker-exposed ankylosing spondylitis patients
3. Ten TNF blocker-naïve nrSpA patietns
4. Ten TNF blocker-exposed nrSpA patients
5. Ten healthy age, diet and BMI-matched controls Inclusion and exclusion criteria will vary by study group. It is anticipated that the TNF-blocker naïve groups will be the most difficult to recruit, so these groups will serve as the baseline for age and diet matching for the other two groups. Up to seventy (70) additional TNF-treated axial SpA and healthy subjects may be asked to complete the dietary questionnaire, but will not provide stool samples unless age, diet and BMI-matched with a TNF-blocker-naïve axial SpA subject.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
TNF blocker-naïve ankylosing spondylitis patients
TNF blocker-exposed ankylosing spondylitis patients
TNF blocker-naïve nrSpA patients
TNF blocker-exposed nrSpA patients
Healthy Participants

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eyal Kedar

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 9, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: EK001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No