Clinical trial NCT02962479: Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Axial Spondyloarthritis
Ankylosing Spondylitis
Lead sponsor: St. Lawrence Health System
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weighted and unweighted UniFrac distances between stool samples from the five study groups
timeFrame: Within 1 month of baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Potsdam
country: United States
facility: St. Lawrence Health System
state: New York
Study officials:
References: