Идёт набор NCT03839862

Faecal Analyses in Spondyloarthritis Therapy

— Наблюдательное Spondyloarthropathies Ankylosing Spondylitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: TNF-inhibition.
Кому может быть актуально: Состояния в реестре: Spondyloarthropathies, Ankylosing Spondylitis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Change in gut flora [Срок оценки: Change from baseline Dysbiosis Index Score at 6 months]
Change in disease activity/treatment response at follow up [Срок оценки: Change from baseline BASDAI at 6 months]

Вторичные конечные точки (3)

Intestinal gut flora in spondyloarthropathies [Срок оценки: Analysis made at study start /baseline]
Intestinal gut inflammation [Срок оценки: Analysis made at study start /baseline]
Adherence to immunosuppressive therapy [Срок оценки: Analysis made at 6 months follow up]

Критерии участия

Критерии включения

Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
About to commence treatment with TNF-inhibition