Stool Transplant Tested for Axial Spondyloarthritis Patients
Tests a stool microbiota transplant against placebo in adults with axial spondyloarthritis.
Plain-language title generated from the registry record
Registry title: Fecal Microbiota Transplantation in Axial Spondyloarthritis
Key facts
- Where
- Tromsø, NorwaySee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06451588, who can take part
Where in Norway
- University Hospital North NorwayTromsø, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital of North Norway
- Trial code
- NCT06451588
- Record updated
- 14 August 2026
- Original description
Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints.Read full original descriptionShow less
Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial
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.
Inclusion: 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; On stable immunomodulatory treatment (TNFi, IL17i or JAKi) the last 3 months OR without immunomodulatory treatment last 3 months.
Exclusion: Severe immune deficiency (acquired, congenital og du to medication); Previous treatment with FMT; Abdominal surgery excluding appendectomy, cholecystectomy, hysterectomy, caesarian section, sapling-ooforectomy and hernia surgery; 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; 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; Malignant disease excluding basalioma and melanoma stage 1; Disease or disorder with life expectancy of ≤5 years; Planned dose adjustment or change in immunomodulatory treatment the next 90 days; Regular use of opioids with the exception of codeine and tramadol; Microscopic colitis, diverticulitis or ileus; Active psoriasis; Fibromyalgia; 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.