Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints.
It has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy.
The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy.
The main questions it aims to answer are:
* Can FMT reduce disease activity in axial SpA? * Can FMT alleviate pain and reduce fatigue in axial SpA? * Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT?
Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.
Axial Spondyloarthritis according to the ASAS classification criteria
Active disease defined as ASDAS ≥2.1 with elevated CRP ≥3 OR active inflammation on MRI within the last 3 months
Onset of axial SpA within last 10 years
Unsatisfactory relief of NSAIDs
Planned dose adjustment or change in immunomodulatory treatment the next 90 days
Disease or disorder with life expectancy of ≤5 years
Severe immune deficiency (acquired, congenital og du to medication)
Previous treatment with FMT
Parallel
FMT
DrugActive FMT
Placebo
DrugThe placebo treatment will be prepared based on the patients' fecal samples (autologous).
Minimal Clinically Important Improvement
Proportion of patients that meet the criteria of Minimal Clinically Important Improvement in the donor FMT (dFMT) versus the autologous FMT (aFMT) group at day 90 after treatment (FMT - Fecal Microbiota Transplantation). Minimal Clinically Important Improvement is defined by a decrease of ≥1,1 in ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score).
Adverse events
The proportion of patients experiencing any adverse events from baseline util day 90 and day 365
Assessment in Spondyloarthritis International Society (ASAS)20
Improvement of at least 20% in 3 out of four domains without worsening of 20% or more in the remaining domain. Change in the dFMT vs aFMT group from baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, 0-10)
Higher score indicates more active disease. Change in the dFMT vs aFMT group from baseline
Bath Ankylosing Spondylitis Funtional Index (BASFI, 0-10)
Higher score indicating more severe disease impact. Change in the dFMT vs aFMT group from baseline
Exploratory endpoint
Changes in taxonomy and function of the microbiome, the immune system, metabolome and gut epithelial barrier in participants with vs without treatment success to dFMT and aFMT
Exploratory endpoint
Differences in baseline taxonomy and function of the microbiome, the immune system, metabolome and gut epithelial barrier in participants with vs without treatment success to dFMT and aFMT
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University Hospital of North Norway
Lead sponsor
Helse Nord
Collaborator
