Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2019-01-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Responder
Patient responding to TNF-inhibition
TNF-inhibition
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
non-Responder
Patient not responding to TNF-inhibition
TNF-inhibition
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
Interventions
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TNF-inhibition
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
Eligibility Criteria
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Inclusion Criteria
* About to commence treatment with TNF-inhibition
Exclusion Criteria
* A history of alcohol abuse
* Any history of diverticulitis
* A history of failure to comply with prescribed medication
* Ongoing biological therapy
18 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Kristofer Andréasson, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University Hospital
Locations
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Reumatologi SUS Lund, Region Skåne
Lund, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FAST1
Identifier Type: -
Identifier Source: org_study_id
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