Analyzing gut bacteria in patients with spondyloarthritis receiving treatment
Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.
This study is trying to see how gut bacteria might affect how well people with spondyloarthritis respond to a specific treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT03839862 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with spondyloarthropathy who are about to start TNF-inhibition therapy.
Not a fit: Patients with a history of alcohol abuse, diverticulitis, or those currently on biological therapy may not benefit from this study.
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 performed: While the association between gut microbiome and spondyloarthropathies is being explored, this specific observational approach is relatively novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Lund
- Reumatologi SUS Lund, Region Skåne — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Kristofer Andréasson, MD PhD — Lund University Hospital
- Study coordinator: Kristofer Andréasson, MD PhD
- Email: kristofer.andreasson@med.lu.se
- Phone: +4646172153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.