NCT06451588 Fecal Microbiota Transplantation in Axial Spondyloarthritis
| NCT ID | NCT06451588 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital of North Norway |
| Condition | Axial Spondyloarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 99 participants in total. It began in 2024-06-01 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06451588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Axial Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06451588 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06451588 currently recruiting?
Yes, NCT06451588 is actively recruiting participants. Contact the research team at gunnstein.bakland@unn.no for enrollment information.
Where is the NCT06451588 trial being conducted?
This trial is being conducted at Tromsø, Norway.
Who is sponsoring the NCT06451588 clinical trial?
NCT06451588 is sponsored by University Hospital of North Norway. The trial plans to enroll 99 participants.