Faecal Analyses in Spondyloarthritis Therapy

Ankylosing Spondylitis Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839862
• Other study ID #: FAST1
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Region Skane
• Contact: Kristofer Andréasson, MD PhD
• Phone: +4646172153
• Email: kristofer.andreasson[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylarthropathies
• Spondylitis
• Spondylitis, Ankylosing
• Spondyloarthropathies

Intervention

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

Locations

Country	Name	City	State
Sweden	Reumatologi SUS Lund, Region Skåne	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gut flora	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.	Change from baseline Dysbiosis Index Score at 6 months
Primary	Change in disease activity/treatment response at follow up	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 from baseline BASDAI at 6 months
Secondary	Intestinal gut flora in spondyloarthropathies	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.	Analysis made at study start /baseline
Secondary	Intestinal gut inflammation	Assessment of intestinal inflammation by measurement of faecal calprotectin, an established biomarker of intestinal inflammation	Analysis made at study start /baseline
Secondary	Adherence to immunosuppressive therapy	Is the patient still prescribed the same immunosuppressant compared to baseline?	Analysis made at 6 months follow up