Faecal Analyses in Spondyloarthritis Therapy

Recruiting

• Conditions: Spondyloarthropathies; Ankylosing Spondylitis
• Interventions: Drug: TNF-inhibition

• Registration Number: NCT03839862
• Lead Sponsor: Region Skane

Brief 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.

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Responder	TNF-inhibition	Patient responding to TNF-inhibition
non-Responder	TNF-inhibition	Patient not responding to TNF-inhibition

Primary Outcome Measures

Name	Time	Method
Change in disease activity/treatment response at follow up	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
Change in gut flora	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.

Secondary Outcome Measures

Name	Time	Method
Intestinal gut flora in spondyloarthropathies	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.
Intestinal gut inflammation	Analysis made at study start /baseline	Assessment of intestinal inflammation by measurement of faecal calprotectin, an established biomarker of intestinal inflammation
Adherence to immunosuppressive therapy	Analysis made at 6 months follow up	Is the patient still prescribed the same immunosuppressant compared to baseline?

Trial Locations

Locations (1)

Reumatologi SUS Lund, Region Skåne; 🇸🇪 Lund, Sweden