Faecal Analyses in Spondyloarthritis Therapy (FAST)
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| ClinicalTrials.gov Identifier: NCT03839862 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : March 20, 2020
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Spondyloarthropathies Ankylosing Spondylitis | Drug: TNF-inhibition |
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 Type : | Observational |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition. |
| Actual Study Start Date : | January 1, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Responder
Patient responding to TNF-inhibition
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Drug: TNF-inhibition
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab |
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non-Responder
Patient not responding to TNF-inhibition
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Drug: TNF-inhibition
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab |
- 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.
- 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
- 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.
- 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
- Adherence to immunosuppressive therapy [ Time Frame: Analysis made at 6 months follow up ]Is the patient still prescribed the same immunosuppressant compared to baseline?
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
This study encompasses consecutive patients with spondyloarthropathy who by their physician at the Rheumatology Clinic, Skåne University Hospital, have been prescribed a TNF-inhibitor.
Patients who are willing to comply with the study protocoll are included. The study population is consequently not a sample, but encompasses a majority of spondyloarthropathy patients being prescribed this medication at our University clinic.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839862
| Contact: Kristofer Andréasson, MD PhD | +4646172153 | kristofer.andreasson@med.lu.se | |
| Contact: Johan Karlsson Wallman, MD PhD | +4646172140 | johan.81.karlsson@gmail.com |
| Sweden | |
| Reumatologi SUS Lund, Region Skåne | Recruiting |
| Lund, Sweden, 221 85 | |
| Contact: Kristofer Andréasson, MD PhD +4646171000 kristofer.andreasson@med.lu.se | |
| Contact: Johan Karlsson Wallman, MD PhD +4646171000 johan.81.karlsson@gmail.com | |
| Principal Investigator: | Kristofer Andréasson, MD PhD | Lund University Hospital |
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT03839862 |
| Other Study ID Numbers: |
FAST1 |
| First Posted: | February 15, 2019 Key Record Dates |
| Last Update Posted: | March 20, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Spondylitis Spondylitis, Ankylosing Spondylarthritis Spondylarthropathies Bone Diseases, Infectious Infections |
Bone Diseases Musculoskeletal Diseases Spinal Diseases Ankylosis Joint Diseases Arthritis |