Faecal Analyses in Spondyloarthritis Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TNF-inhibition.
- Who it may be relevant to
- Registry conditions: Spondyloarthropathies, Ankylosing Spondylitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.
Overview
This study evaluates the intestinal microbiome and disease activity in patients with spondyloarthropathies receiving immunosuppressive therapy. Patients will be analysed at two time points in reference to two predefined primary endpoints: * Changes in intestinal microbiome * Response to therapy The investigators want to evaluate if successful treatment of spondylarthropathy coincide with specific changes in the gut flora.
Detailed description
Tumor necrosis factor (TNF)-inhibition is an efficient medication for the treatment of spondyloarthropathy. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to this medication. The purpose of this study is to understand if the gut flora may associate with treatment response.
Spondyloarthropathies are associated with inflammatory bowel diseases in terms of epidemiology and molecular pathogenesis. Recent studies have also associated spondyloarthropathies with intestinal dysbiosis.
This study is of observational character and integrated in the routine clinical care of patients with spondyloarthropathies at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other.
Our primary goal is to investigate the association between change in intestinal microbiome and clinical response to therapy.
In our secondary analyses we will investigate if intestinal microbiome and intestinal inflammation at baseline may predict response to, and adherence to, therapy in these patients.
If successful treatment response of spondyloarthropathy is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.
Interventions
- Drug TNF-inhibition
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
Primary outcome measures
- Change in gut flora [Time frame: Change from baseline Dysbiosis Index Score at 6 months]
- Change in disease activity/treatment response at follow up [Time frame: Change from baseline BASDAI at 6 months]
Secondary outcome measures (3)
- Intestinal gut flora in spondyloarthropathies [Time frame: Analysis made at study start /baseline]
- Intestinal gut inflammation [Time frame: Analysis made at study start /baseline]
- Adherence to immunosuppressive therapy [Time frame: Analysis made at 6 months follow up]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Reumatologi SUS Lund, Region Skåne — Lund
Identifiers
NCT: NCT03839862 · FAST1