Clinical trial for Axial Spondyloarthritis
Official title Fecal Microbiota Transplantation in Axial Spondyloarthritis
ClinicalTrials.gov ID: NCT06451588
What this study is testing
What is FMT?
FMT is an investigational medicine, being studied as a potential treatment for axial spondyloarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tromsø, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tromsø, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.