Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in disease activity/treatment response at follow up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
- •About to commence treatment with TNF-inhibition
排除标准
- •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
研究组 & 干预措施
Responder
Patient responding to TNF-inhibition
干预措施: TNF-inhibition (Drug)
non-Responder
Patient not responding to TNF-inhibition
干预措施: TNF-inhibition (Drug)
结局指标
主要结局
Change in disease activity/treatment response at follow up
时间窗: 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
时间窗: 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.
次要结局
- Intestinal gut flora in spondyloarthropathies(Analysis made at study start /baseline)
- Intestinal gut inflammation(Analysis made at study start /baseline)
- Adherence to immunosuppressive therapy(Analysis made at 6 months follow up)