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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of fecal microbiota transplantation (FMT) as a new treatment option for patients with axial spondyloarthritis (axSpA) who have not responded well to standard treatments. Axial spondyloarthritis is a type of inflammatory arthritis affecting the spine and pelvis, and many patients find that their current medications, which can be expensive and come with side effects, do not provide enough relief. The trial aims to see if FMT can help restore a healthy balance of gut bacteria (the microbiome) and improve symptoms in these patients.

To participate in this study, you need to be between 18 and 75 years old and have active axSpA, experiencing significant pain and inflammation despite using multiple medications, including non-steroidal anti-inflammatory drugs (NSAIDs) and biologic treatments. Participants will receive either the FMT treatment or a placebo (a non-active treatment) to compare the effects. Throughout the trial, participants can continue their stable medications, and they will be closely monitored for safety and effectiveness. This research is important because it could lead to new treatment options for people struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 1. Patient under legal protection (guardianship or curatorship)
• • 2. 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
• • 3. Pregnant or breastfeeding woman
• • 4. Patient with IBD in active state, according to the judgment of the Investigator
• • 5. Corticosteroid injection within 4 weeks before inclusion
• • 6. Active infection according to the judgment of the Investigator
• • 7. Any antibiotic (including Sulfasalazin) or antifungal treatment within 4 weeks before inclusion
• • 8. Probiotics intake within 4 weeks before inclusion
• • 9. Known infection with Clostridoides difficile or Escherichia coli within 10 days before inclusion
• • 10. Patients with unstable severe condition other than axial SpA on that could jeopardize treatment procedure or evaluation according to the investigator's assessment
• • 11. Previous FMT treatment
• • 12. Contra-indication to colon preparation (Moviprep® or Moviprep orange®) according to SmPC
• • 13. Current or past evidence of bowel obstruction
• • 14. Confirmed or suspected intestinal ischemia
• • 15. Confirmed or suspected toxic megacolon or gastrointestinal perforation
• • 16. Extended colectomy (\> two-thirds of colon)
• • 17. Any gastro-intestinal bleeding in the past 3 months before inclusion
• • 18. Any history of gastro-intestinal surgery in the past 3 months before inclusion
• • 19. Severe organ dysfunction
• • 20. Any contra-indication to swallow capsules
• • 21. Known allergy or intolerance to IMP and / or excipients according to Investigator's Brochure
• • 22. Lack of access to a refrigerator to store the medication (MaaT033® or MaaT030®)
• • 23. Concomitant participation in another interventional clinical trial

Trial Officials