Faecal Analyses in Spondyloarthritis Therapy (FAST)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    50
  • sponsor
    Region Skane
Updated on 2 March 2022
adalimumab
infliximab
tumor necrosis factor
etanercept
immunosuppressants
spondyloarthropathy
spondyloarthropathies

Summary

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.

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.

Details
Condition Spondyloarthropathies, Ankylosing Spondylitis
Treatment TNF-inhibition
Clinical Study IdentifierNCT03839862
SponsorRegion Skane
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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