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NCT Number: NCT03839862

Faecal Analyses in Spondyloarthritis Therapy

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.

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Key information

Conditions

Spondyloarthropathies Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNF-inhibition

Drug

Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab

Primary outcomes

  1. Change in gut flora

    Time frame: Change from baseline Dysbiosis Index Score at 6 months

    Change in Dysbiosis Index Score att follow up compared to baseline. The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.

  2. Change in disease activity/treatment response at follow up

    Time frame: Change from baseline BASDAI at 6 months

    Change in Bath Ankylosing Spondylitis Disease Activity Score (BASDAI), an established index of disease activity in spondylarthropathies between 0-10, where 10 equals maximum activity

Secondary outcomes

  1. Intestinal gut flora in spondyloarthropathies

    Time frame: Analysis made at study start /baseline

    Intestinal gut flora based on DNA-based microbial analysis of fecal samples (Dysbiosis Index Score). The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.

  2. Intestinal gut inflammation

    Time frame: Analysis made at study start /baseline

    Assessment of intestinal inflammation by measurement of faecal calprotectin, an established biomarker of intestinal inflammation

  3. Adherence to immunosuppressive therapy

    Time frame: Analysis made at 6 months follow up

    Is the patient still prescribed the same immunosuppressant compared to baseline?

Study contacts

Contact information is provided by the study sponsor or research team.

Johan Karlsson Wallman, MD PhD

CONTACT

[email protected]

+4646172140

Kristofer Andréasson, MD PhD

CONTACT

[email protected]

+4646172153

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Acronym: FAST

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2019
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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