Actively Recruiting
Fecal Microbiota Transplantation in Axial Spondyloarthritis
Led by University Hospital of North Norway · Updated on 2024-06-11
99
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University Hospital of North Norway
Lead Sponsor
H
Helse Nord
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Axial Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial Spondyloarthritis according to ASAS classification criteria
- Active disease defined as ASDAS score 2.1 or higher with elevated CRP 4 or more, or active inflammation on MRI within last 3 months
- Onset of axial SpA within the past 10 years
- Unsatisfactory relief of symptoms from NSAIDs
- Stable immunomodulatory treatment (TNFi, IL17i, or JAKi) for at least 3 months prior to enrollment
You will not qualify if you...
- Planned dose adjustment or change in immunomodulatory treatment within the next 90 days
- Life expectancy of 5 years or less due to disease or disorder
- Severe immune deficiency (acquired, congenital, or medication-induced)
- Previous treatment with fecal microbiota transplantation
- Regular opioid use except codeine and tramadol
- Any diagnosis explaining or causing back pain other than axSpA (e.g., tumor, fracture, infection, degenerative disease)
- Inflammatory spinal disease other than axial Spondyloarthritis
- Severe psychiatric disorder, alcohol or drug abuse
- Active inflammatory bowel disease
- Microscopic colitis, diverticulitis, or ileus
- Active psoriasis
- Fibromyalgia
- Abdominal surgery except appendectomy, cholecystectomy, hysterectomy, cesarean section, salpingo-oophorectomy, or hernia surgery
- Malignant disease except basal cell carcinoma and stage 1 melanoma
- Expected need for antibiotics during the study (e.g., periodontitis, ischemic digital ulcers)
- Antibiotic treatment within 12 weeks prior to study entry
- Pregnancy, lactation, or planned pregnancy within 3 months
- Contraindications to rectal catheter insertion
- Planned rehabilitation program within next 90 days
- Limited ability to comply with protocol, including biobank participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital North Norway
Tromsø, Norway, 9038
Actively Recruiting
Research Team
G
Gunnstein Bakland, MD PhD
CONTACT
P
Peter Johnsen, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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