Fecal Microbiota Transplantation in Axial Spondyloarthritis

Launched by UNIVERSITY HOSPITAL OF NORTH NORWAY · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of fecal microbiota transplantation (FMT) as a potential treatment for patients with axial spondyloarthritis (axSpA) who are not getting enough relief from their current medications. The researchers want to find out if FMT can help reduce disease activity, lessen pain, and improve fatigue in these patients. The trial will involve giving participants either a treatment with donor fecal material or a placebo (a substance with no active ingredients) through an enema. The main outcomes will be measured after 90 days, but the researchers will keep track of how everyone is doing for a full year.

To participate, individuals must be diagnosed with axial spondyloarthritis and have active disease despite taking stable immunomodulatory treatments. They should also have experienced insufficient relief from non-steroidal anti-inflammatory drugs (NSAIDs). Some people may not be eligible if they have certain other health conditions, are pregnant, or have had previous fecal transplants. This trial is currently recruiting participants, and it offers a unique opportunity to explore a new approach for managing this challenging condition.

Gender

ALL

Eligibility 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