NCT06451588RecruitingPhase 2
Fecal Microbiota Transplantation in Axial Spondyloarthritis
Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 4 Jun 2024
- Start date
- 1 Jun 2024
- Primary completion date
- May 2027
- Lead sponsor
- University Hospital of North Norway
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06451588
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 99
- From 1 Jun 2024 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Disease or disorder with life expectancy of ≤5 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.