Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05654753

PHASE2/PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: RANDOMIZED DOUBLE BLIND CONTROLLED STUDY ASSESSING THE EFFICACY OF FECAL MICROBIOTA TRANSPLANTATION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RESISTANT TO CONVENTIONAL TREATMENT

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-03-28

Completion Date

2027-09

Last Updated

2024-04-09

Healthy Volunteers

Conditions

Axial Spondyloarthritis

Interventions

DRUG

active FMT

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.

DRUG

Placebo

Patients will receive 20 capsules placebo, each containing placebo at once at day 0, then 3 capsules/day from day 1 through day 20.

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

Locations (1)

Rheumatology Department, Ambroise Paré hospital - APHP

Boulogne-Billancourt, France