Axial SpondyloarthritisNCT02962479
Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?
An observational study of Axial Spondyloarthritis and Ankylosing Spondylitis, run by Eyal Kedar at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Able to provide informed consent
- Male or Female patients ≥18 years of age
- Additional Inclusion Criteria based on cohort
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TNF blocker-naïve ankylosing spondylitis patients | Not described | |
| TNF blocker-exposed ankylosing spondylitis patients | Not described | |
| TNF blocker-naïve nrSpA patients | Not described | |
| TNF blocker-exposed nrSpA patients | Not described | |
| Healthy Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted and unweighted UniFrac distances between stool samples from the five study groups
Measured: Within 1 month of baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eyal Kedar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eyal Kedar, St. Lawrence Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962479
- Sponsor's protocol ID
- EK001
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?
- ClinicalTrials.gov ID
- NCT02962479
- Acronym / sponsor ID
- EK001
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eyal KedarUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TNF blocker-naïve ankylosing spondylitis patients | – | – |
| TNF blocker-exposed ankylosing spondylitis patients | – | – |
| TNF blocker-naïve nrSpA patients | – | – |
| TNF blocker-exposed nrSpA patients | – | – |
| Healthy Participants | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Able to provide informed consent
- Male or Female patients ≥18 years of age
- Additional Inclusion Criteria based on cohort
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weighted and unweighted UniFrac distances between stool samples from the five study groups
Time frame: Within 1 month of baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis and Ankylosing Spondylitis, run by Eyal Kedar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weighted and unweighted UniFrac distances between stool samples from the five study groups (time frame: Within 1 month of baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.