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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. In addition, these are extremely expensive treatments that expose them to the risk of potentially serious side effects. Compelling evidence indicates that gut dybiosis could be a critical trigger of inflammation in axial SpA and thus correcting dysbiosis represents an attractive way of reversing the pathogenic process.The efficacy of FMT in patients with axial SpA has never been studied. This randomized double-blind study will be the first to assess feasability of FMT in axial SpA, the capacity of this procedure to restore healthy microbiome, its tolerance and its potential efficacy on disease activity. If sucessfull, this trial would set the path to larger-scale clinical trials of FMT to treat axial SpA.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Fondation Arthritis & Clarins Worldwide 2016

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