The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment (FMT-SpA)
Axial Spondyloarthritis
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring Axial Spondyloarthritis, dysbiotic microbiota, Fecal microbiota transplantation, eubiotic microbiota
Eligibility Criteria
Inclusion Criteria: Adult patient (age 18 to 90 years old) with SpA, meeting the ASAS classification criteria for axial SpA, with presence of radiographic sacro-illitis (ankylosing spondylitis) or not. Patient suffering of active SpA, with or without treatment, having a BASDAI score ≥ 4 (0-10) at baseline and a score of back pain ≥ 4 (0-10) despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 2 months (or less in case of intolerance or contra-indication) and at least a first line of biotherapy (anti-TNFα or anti-IL-17) for at least 4 months (or less in case of intolerance or contra-indication). Subjects are allowed to continue NSAID, sulfasalazin (≤ 3 g/day) and/or methotrextae ( ≤ 25 mg/week) and/or hydroxychloroquine (≤ 400 mg/day) and/or oral corticosteroid (≤ 10 mg/day of prednisone), as long as these treatments have remained at stable dose for 4 weeks prior to baseline. Subjects are allowed to continue anti-TNFα, anti-IL-17 or JAKinhibitor therapies, as long as these treatments have remained at stable dose for 3 months prior to baseline. Exclusion Criteria: Patient under guardianship Refusal to participate to the study or to sign the informed consent Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development Women of childbearing potential without efficient contraceptive protection Pregnant or breastfeeding woman Patient with active IBD Corticosteroid injection within 4 weeks before inclusion Active uncontrolled infection according to the attending physician Antibiotic or antifungic treatment within 4 weeks before inclusion Probiotics intake within 4 weeks before inclusion Confirmed positive result to SARS-CoV-2 test at screening Infection with Clostridium difficile within 10 days before inclusion Patients with unstable severe condition other than axial SpA on that could jeopardize treatment procedure or evaluation No affiliation to a social security scheme Previous FMT treatment Contra-indication to colon preparation (Moviprep®) Confirmed or suspected intestinal ischemia Confirmed or suspected toxic megacolon or gastrointestinal perforation Any gastro-intestinal bleeding in the past 3 months Any history of gastro-intestinal surgery in the past 3 months Severe organ dysfunction Any contra-indication to swallow capsules Known allergy or intolerance to trehalose, maltodextrin or PEG Patients with EBV-negative serology
Sites / Locations
- Rheumatology Department, Ambroise Paré hospital - APHP
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental
Placebo
active FMT
placebo