Ankylosing Spondylitis Clinical Trial
— MicroSpAOfficial title:
Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial
NCT number | NCT06451588 |
Other study ID # | 537025 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 1, 2024 |
Est. completion date | March 2026 |
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: - Can FMT reduce disease activity in axial SpA? - Can FMT alleviate pain and reduce fatigue in axial SpA? - Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT? 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.
Status | Recruiting |
Enrollment | 99 |
Est. completion date | March 2026 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Axial Spondyloarthritis according to the ASAS classification criteria - Active disease defined as ASDAS =2.1 with elevated CRP =4 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 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 |
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital North Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | Helse Nord |
Norway,
Baraliakos X, Braun J. Spondyloarthritides. Best Pract Res Clin Rheumatol. 2011 Dec;25(6):825-42. doi: 10.1016/j.berh.2011.11.006. — View Citation
Bazin T, Hooks KB, Barnetche T, Truchetet ME, Enaud R, Richez C, Dougados M, Hubert C, Barre A, Nikolski M, Schaeverbeke T. Microbiota Composition May Predict Anti-Tnf Alpha Response in Spondyloarthritis Patients: an Exploratory Study. Sci Rep. 2018 Apr 3 — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | baseline and day 90 | |
Other | 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 | baseline | |
Primary | 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. Minimal Clinically Important Improvement is defined by a decrease of =1,1 in ASDAS-CRP | 90 days | |
Secondary | Adverse events | The proportion of patients experiencing any adverse events from baseline util day 90 and day 365 | Day 0-90 and day 91-365 | |
Secondary | Ankylosing Spondylitis Disease Activity Score (ASDAS)20 | Change in the dFMT vs aFMT group from baseline | baseline, day 30, day 60 and day 90 | |
Secondary | Bath Ankylosing Spondylitis Disease Activity Index | Change in the dFMT vs aFMT group from baseline | baseline, day 30, day 60 and day 90 | |
Secondary | Bath Anykylosing Spondylitis Funtional Index | Change in the dFMT vs aFMT group from baseline | baseline, day 30, day 60 and day 90 | |
Secondary | Patient global assessment | Change in the dFMT vs aFMT group from baseline | baseline, day 30, day 60 and day 90 | |
Secondary | VAS spinal pain | Change in the dFMT vs aFMT group from baseline | baseline, day 30, day 60 and day 90 | |
Secondary | Modified Fatigue Impact Scale | Change in the dFMT vs aFMT group from baseline | baseline and day 90 | |
Secondary | RAND-36 | Change in the dFMT vs aFMT group from baseline | baseline and day 90 | |
Secondary | Maastricht Ankylosing Spondylitis Enthesitis Score | Change in the dFMT vs aFMT group from baseline | baseline and day 90 | |
Secondary | The 66/68 Joint Count Score | Change in the dFMT vs aFMT group from baseline | baseline and day 90 | |
Secondary | Bath Ankylosing Spondylitis Metrology Index | Change in the dFMT vs aFMT group from baseline | baseline and day 90 | |
Secondary | Ankylosing Spondylitis Disease Activity Score (ASDAS)40 | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 | |
Secondary | Bath Ankylosing Spondylitis Disease Activity Index | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 | |
Secondary | Bath Anykylosing Spondylitis Funtional Index | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 | |
Secondary | Patient global assessment | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 | |
Secondary | VAS spinal pain | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 | |
Secondary | Modified Fatigue Impact Scale | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 | |
Secondary | RAND-36 | Long term change that includes the extended open labeled follow up in the dFMT vs aFMT group from baseline | baseline and day 30, day 60, day 90, day 180, day 270 and day 365 |
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