Fecal Microbiota Transplantation in Axial Spondyloarthritis
Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial
University Hospital of North Norway
99 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Axial Spondyloarthritis according to the ASAS classification criteria
- Active disease defined as ASDAS ≥2.1 with elevated CRP ≥4 OR active inflammation on MRI within the last 3 months
- Onset of axial SpA within last 10 years
- Unsatisfactory relief of NSAIDs
- On stable immunomodulatory treatment (TNFi, IL17i or JAKi) the last 3 months
Exclusion Criteria20
- 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
- Regular use of opioids with the exception of codeine and tramadol
- Any specific diagnosis that could explain or contribute to the patients back pain (e.g. tumor, fracture, infection or degenerative disease)
- Inflammatory spinal disease other than axSpA
- Severe psychiatric disorder, alcohol- or drug abuse
- Active inflammatory bowel disease
- Microscopic colitis, diverticulitis or ileus
- Active psoriasis
- Fibromyalgia
- Abdominal surgery excluding appendectomy, cholecystectomy, hysterectomy, caesarian section, sapling-ooforectomy and hernia surgery
- Malignant disease excluding basalioma and melanoma stage 1
- Conditions with expected necessary treatment with antibiotics during the study period, e.g. periodontitis end ischemic digital ulcers
- Treatment with antibiotics 12 weeks prior to study entry
- Pregnancy, lactation or planned pregnancy within the next 3 months
- Contraindications for rectal catheter insertion
- Planned rehabilitation program the next 90 days
- Limited ability to comply with protocol requirements, including biobank participation
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Interventions
Active FMT
The placebo treatment will be prepared based on the patients' fecal samples (autologous).
Locations(1)
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NCT06451588