Axial Spondyloarthritis study: FMT
Official title Fecal Microbiota Transplantation in Axial Spondyloarthritis
ClinicalTrials.gov ID: NCT06451588
What this study is testing
What is FMT?
FMT is an investigational treatment being studied to see if it can help people with axial spondyloarthritis who did not get enough relief from other medicines. It is designed to replace the gut bacteria with healthy donor bacteria to see if this changes the body's immune response.
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
- This study is testing whether a stool transplant can lower disease activity, pain, and fatigue in people with axial spondyloarthritis who do not get enough relief from biologic medicines.
- Who it's for
- You may be able to join if you have axial spondyloarthritis and are already using biologic therapy but still have symptoms.
- What's involved
- You would receive one enema that contains either donor stool (fecal microbiota transplant) or a pretend treatment. You will have check‑ins and tests for up to a year.
- Time commitment
- The study lasts about one year with a main visit at 90 days and follow‑up visits through 365 days.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Tromsø, Norway. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.