The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment

Korábbi kezelés

• Corticosteroid injection within 4 weeks before inclusion
• Any antibiotic (including Sulfasalazin) or antifungal treatment within 4 weeks before inclusion
• Probiotics intake within 4 weeks before inclusion
• Known infection with Clostridoides difficile or Escherichia coli within 10 days before inclusion
• Previous FMT treatment
• Any gastro-intestinal bleeding in the past 3 months before inclusion
• Any history of gastro-intestinal surgery in the past 3 months before inclusion
• Lack of access to a refrigerator to store the medication (MaaT033® or MaaT030®)
• Concomitant participation in another interventional clinical trial

Más betegség

• Active infection according to the judgment of the Investigator
• Patients with unstable severe condition other than axial SpA on that could jeopardize treatment procedure or evaluation according to the investigator's assessment
• Confirmed or suspected toxic megacolon or gastrointestinal perforation
• Known allergy or intolerance to IMP and / or excipients according to Investigator's Brochure

Egyéb

• Patient under legal protection (guardianship or curatorship)
• 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
• Pregnant or breastfeeding woman
• Patient with IBD in active state, according to the judgment of the Investigator
• Contra-indication to colon preparation (Moviprep® or Moviprep orange®) according to SmPC
• Current or past evidence of bowel obstruction
• Confirmed or suspected intestinal ischemia
• Extended colectomy (> two-thirds of colon)
• Severe organ dysfunction
• Any contra-indication to swallow capsules

• Adult patient (age 18 to 75 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.
• Women of childbearing potential with efficient contraceptive protection at the inclusion and during at least the interventional phase (D168).
• Patient with health insurance (AME except).
• Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol.