Fecal microbiota transplantation for treating axial spondyloarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion 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

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 it's running

• University Hospital North Norway
  Tromsø, Norway Recruiting

Study contacts

• Study coordinator: Gunnstein Bakland, MD PhD
• Email: gunnstein.bakland@unn.no
• Phone: +4795860791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.