Clinical trial Recruiting at 1 site Observational Ages 18 and up

Analyzing gut bacteria in patients with spondyloarthritis receiving treatment

Official title: Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.

Run by Region Skane · NCT03839862 · Data updated 2026-11-12

This study is trying to see how gut bacteria might affect how well people with spondyloarthritis respond to a specific treatment.

More Ankylosing Spondylitis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorRegion Skane
Academic / other
Locations1 site (Lund)
StatusRecruiting
StartedJanuary 1, 2019
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedMarch 6, 2024
Trial IDNCT03839862 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients diagnosed with spondyloarthropathy who are about to start TNF-inhibition therapy.

Probably not a fit

Patients with a history of alcohol abuse, diverticulitis, or those currently on biological therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the relationship between the intestinal microbiome and disease activity in patients with spondyloarthropathies undergoing TNF-inhibition therapy. Participants will provide blood and fecal samples at two time points to assess changes in gut flora and response to treatment. The study aims to understand why some patients do not respond to TNF-inhibition and whether specific changes in gut bacteria correlate with treatment outcomes. A total of 50 patients are expected to be included, with a focus on comparing responders and non-responders to therapy.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for patients with spondyloarthritis based on their gut microbiome.

How similar studies have gone: While the association between gut microbiome and spondyloarthropathies is being explored, this specific observational approach is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
* About to commence treatment with TNF-inhibition

Exclusion Criteria:

* Failure to understand protocol
* A history of alcohol abuse
* Any history of diverticulitis
* A history of failure to comply with prescribed medication
* Ongoing biological therapy

Where it's running

  • Reumatologi SUS Lund, Region Skåne
    Lund, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.