Could a gut microbiome transplant ease axial spondyloarthritis?

NCT ID NCT06451588

Disease control Sponsor: University Hospital of North Norway Source: ClinicalTrials.gov ↗

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether transferring gut bacteria from a healthy donor (fecal microbiota transplantation, or FMT) can reduce disease activity in people with axial spondyloarthritis (axSpA) who haven't fully responded to biologic therapy. Participants receive a single enema with either donor FMT or their own stool (placebo) and are followed for a year. The study aims to see if FMT can improve symptoms like pain and fatigue and restore a healthier gut microbiome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Fecal microbiota transplantation (FMT) via enema
What this could lead to: If effective, FMT could offer a new way to ease symptoms and reduce disease activity in people with axial spondyloarthritis who don't fully respond to biologics.
What could go wrong: This is a phase 2 trial, so results are uncertain. The effect may be modest or not lasting, and there are risks of adverse events from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 99 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis arthritic joint disease arthropathy Axial Spondyloarthritis Dysbiosis musculoskeletal system disorder Spondylarthritis spondylitis spondyloarthropathy vertebral column disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis Arthritis Axial spondyloarthritis Dysbiosis Joint diseases Musculoskeletal diseases Spinal disease Spondylitis Spondyloarthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a gut microbiome transplant ease axial spondyloarthritis?

What the study statuses mean