The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment
RANDOMIZED DOUBLE BLIND CONTROLLED STUDY ASSESSING THE EFFICACY OF FECAL MICROBIOTA TRANSPLANTATION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RESISTANT TO CONVENTIONAL TREATMENT
Assistance Publique - Hôpitaux de Paris
20 participants
Mar 28, 2024
INTERVENTIONAL
Conditions
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. Two-co primary objectives in a hierarchical design: * to evaluate the capacity of FMT to correct dysbiosis in active axial SpA despite well-conducted phamacological treatment by replacing pre-existing dysbiotic microbiota with healthier microbiota. * to explore the efficacy of FMT versus placebo on clinical evolution of SpA.
Eligibility
Inclusion Criteria7
- 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 Criteria23
- 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
- Corticosteroid injection within 4 weeks before inclusion
- Active infection according to the judgment of the Investigator
- 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
- Patients with unstable severe condition other than axial SpA on that could jeopardize treatment procedure or evaluation according to the investigator's assessment
- Previous FMT treatment
- Contra-indication to colon preparation (Moviprep® or Moviprep orange®) according to SmPC
- Current or past evidence of bowel obstruction
- Confirmed or suspected intestinal ischemia
- Confirmed or suspected toxic megacolon or gastrointestinal perforation
- Extended colectomy (> two-thirds of colon)
- Any gastro-intestinal bleeding in the past 3 months before inclusion
- Any history of gastro-intestinal surgery in the past 3 months before inclusion
- Severe organ dysfunction
- Any contra-indication to swallow capsules
- Known allergy or intolerance to IMP and / or excipients according to Investigator's Brochure
- Lack of access to a refrigerator to store the medication (MaaT033® or MaaT030®)
- Concomitant participation in another interventional clinical trial
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Interventions
MaaT033®, a lyophilized full-ecosystem intestinal microbiota delayed release oral capsule containing native, donor-derived (pooled from 4-6 donors) microbiome product manufactured by MaaT Pharma® will be delivered orally. Patients will receive 20 Maat033 capsules, each containing approximatively 0.42 g of microbiome product at once at day 0, then 3 capsules/day from day 1 through day 20.
Patients will receive 20 capsules placebo, each containing placebo at once at day 0, then 3 capsules/day from day 1 through day 20.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05654753