Fecal microbiota transplantation for treating axial spondyloarthritis
Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial
This study is testing if a treatment using gut bacteria from healthy donors can help people with axial spondyloarthritis who aren't feeling better with their current medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø) |
| Trial ID | NCT06451588 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of fecal microbiota transplantation (FMT) in patients with axial spondyloarthritis who have not achieved satisfactory relief from biologic therapies. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives the FMT or a placebo. Participants will receive a single enema treatment and will be monitored for changes in disease activity, pain, and fatigue over a 90-day period. The trial aims to determine if FMT can restore gut microbiota composition and improve symptoms in these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with axial spondyloarthritis who have active disease and have not found relief from NSAIDs or biologic treatments.
Not a fit: Patients with severe immune deficiencies, active inflammatory bowel disease, or those who have previously undergone FMT may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from symptoms for patients with axial spondyloarthritis who do not respond well to current therapies.
How similar studies have performed: While the use of fecal microbiota transplantation is a novel approach in this context, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Tromsø
- University Hospital North Norway — Tromsø, Norway (Recruiting)
Study contacts
- Study coordinator: Gunnstein Bakland, MD PhD
- Email: gunnstein.bakland@unn.no
- Phone: +4795860791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.