A Phase 2 interventional study of FMT and Placebo in Axial Spondyloarthritis, Ankylosing Spondylitis and Dysbiosis, sponsored by University Hospital of North Norway. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University Hospital of North Norway · Phase 2, Interventional, and Treatment
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.
The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy.
The main questions it aims to answer are:
Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.
Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease affecting the sacroiliac joints (SIJ) and the spine.
The approach to treatment of axSpA is a combination of patient education, with a focus on exercise and lifestyle, and a medical treatment. Non-steroidal anti-inflammatory drugs (NSAIDs) are the first-line medical treatment, providing symptom relief for a large portion of the patients. For patients with inadequate response, or intolerance, to NSAIDs, biological (TNFi and IL17i) or targeted synthetic (JAKi) disease modifying drugs (b/ts-DMARDs) are considered a second-line treatment option and provide excellent efficacy for many patients. However, a substantial portion of the patients experience active disease despite this second-line therapy.
The cause of the disease is multifactorial, and both genetic and environmental factors contribute in the pathogenesis. Patients with axSpA have a higher prevalence of inflammatory bowel disease (IBD) than the background population, i.e. Crohn's disease and ulcerative colitis. However, inflammation in the gut is also demonstrated in 50-70% of patients without symptoms of IBD, and this inflammation is believed to be of importance in the development of the disease.
The human gut microbiota is the collection of microbes in the intestines. The composition of the microbiota is the result of many factors and have evolved over time to form a mutually beneficial relationship to both humans and microorganisms. Normally there is a balance and a stability in this composition, but in many conditions an imbalance, termed dysbiosis, has been demonstrated. This is also the case in axSpA, and the extent of this dysbiosis also relates to disease activity and to response to therapy.
Fecal microbiota transplantation (FMT) is a method used to alter the microbiota composition by transferring microbes from a healthy individual to a recipient. In several conditions this has both proven the ability to alter the microbiota and to provide symptom relief , e.g. clostridium difficile infections, ulcerative colitis and irritable bowel syndrome.
In the Microspa study, we aim to evaluate whether fecal microbiota transplantation (FMT) can induce clinical remission and symptom relief in patients with axial spondyloarthritis who have shown an inadequate response to biologic therapy.
Microspa 2 is a parallel trial that retains the overall design of the original study, with adjustments made to the eligibility criteria and primary and secondary endpoints. All other components-including outcome measures, sample size, randomization strategy, and statistical analysis plan-remain unchanged.
In Microspa 2, eligible participants include patients who are biologic-naïve or who have previously used biologic therapy but discontinued treatment. Patients currently receiving biologic therapy are excluded. The primary endpoint is the proportion of patients in the donor FMT group compared to the autologous FMT group who initiate immunomodulatory treatment within 90 days following the intervention. An additional secondary endpoint is the proportion of patients initiating immunomodulatory treatment within 365 days post-intervention.
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's planned enrollment of 99 is above the median of 88 across 302 interventional studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
Compared within Spondylitis, Ankylosing, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Axial Spondyloarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active treatment contain 60g of feces from a single healthy, screened donor. The feces is combined with glycerol and saline to a total volume of 440 ml in an enema bag. Each participant will only receive a single treatment at baseline.
Drug: FMT
Active treatment contain 60g of feces from a single healthy, screened donor. The feces is combined with glycerol and saline to a total volume of 440 ml in an enema bag. Each participant will only receive a single treatment at baseline.
Drug: FMT
Active treatment contain 60g of feces from a single healthy, screened donor. The feces is combined with glycerol and saline to a total volume of 440 ml in an enema bag. Each participant will only receive a single treatment at baseline.
Drug: FMT
Placebo treatment will be processed identically to active treatment, but with paritcipants own stool. The patients in the placebo group will consequently receive an enema with 60g of their own feces combined with glycerol and saline as a single treatment at baseline.
Drug: Placebo
Active FMT
The placebo treatment will be prepared based on the patients' fecal samples (autologous).
Minimal Clinically Important Improvement
Proportion of patients that meet the criteria of Minimal Clinically Important Improvement in the donor FMT (dFMT) versus the autologous FMT (aFMT) group at day 90 after treatment (FMT - Fecal Microbiota Transplantation). Minimal Clinically Important Improvement is defined by a decrease of ≥1,1 in ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score).
Time frame: 90 days
Adverse events
The proportion of patients experiencing any adverse events from baseline util day 90 and day 365
Time frame: Day 0-90 and day 91-365
Assessment in Spondyloarthritis International Society (ASAS)20
Improvement of at least 20% in 3 out of four domains without worsening of 20% or more in the remaining domain. Change in the dFMT vs aFMT group from baseline
Time frame: baseline, day 30, day 60 and day 90
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, 0-10)
Higher score indicates more active disease. Change in the dFMT vs aFMT group from baseline
Time frame: baseline, day 30, day 60 and day 90
Bath Ankylosing Spondylitis Funtional Index (BASFI, 0-10)
Higher score indicating more severe disease impact. Change in the dFMT vs aFMT group from baseline
Time frame: baseline, day 30, day 60 and day 90
Patient global assessment of disease (PGA, 0-10)
Patient's evaluation of disease impact. Higher score indicating worse disease. Change in the dFMT vs aFMT group from baseline
Time frame: baseline, day 30, day 60 and day 90
VAS spinal pain (Visual Analogue Scale, 0-10)
Patient's evaluation of pain on av visual analogue scale. Higher score indicating worse pain. Change in the dFMT vs aFMT group from baseline
Time frame: baseline, day 30, day 60 and day 90
Modified Fatigue Impact Scale (0-84)
Higher score indicating greater impact of fatigue on daily life. Change in the dFMT vs aFMT group from baseline
Time frame: baseline and day 90
RAND-36 (Quality-of-life measure)
Change in the dFMT vs aFMT group from baseline
Time frame: baseline and day 90
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES, 0-13)
Higher score indicating more widespread pain. Change in the dFMT vs aFMT group from baseline
Time frame: baseline and day 90
The 66/68 Joint Count Score
Indicating number of swollen and tender joints. Change in the dFMT vs aFMT group from baseline
Time frame: baseline and day 90
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Indicating restricted mobility. Change in the dFMT vs aFMT group from baseline
Time frame: baseline and day 90
Ankylosing Spondylitis Disease Activity Score (ASDAS)40
Improvement of at least 40% in 3 out of four domains without worsening of 20% or more in the remaining domain.Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, 0-10)
Higher score indicates more active disease. Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
Bath Anykylosing Spondylitis Funtional Index (BASFI, 0-10)
Higher score indicating more severe disease impact. Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
Patient global assessment (PGA, 0-10)
Patient's evaluation of disease impact. Higher score indicating worse disease. Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
VAS spinal pain (0-10)
Patient's assessment of spinal pain og visual scale. Higher score indicates more pain. Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
Modified Fatigue Impact Scale (0-84)
Higher score indicating greater impact of fatigue on daily life. Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
RAND-36
Quality-of-life measure. Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline
Time frame: baseline and day 30, day 60, day 90, day 180, day 270 and day 365
Exploratory endpoint
Changes in taxonomy and function of the microbiome, the immune system, metabolome and gut epithelial barrier in participants with vs without treatment success to dFMT and aFMT
Time frame: baseline and day 90
Exploratory endpoint
Differences in baseline taxonomy and function of the microbiome, the immune system, metabolome and gut epithelial barrier in participants with vs without treatment success to dFMT and aFMT
Time frame: baseline
Plan to share: No — There is not an IPD established.
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