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

Study acronym: FMT-SpA
StatusRecruiting
PhasePhase 2/3
Started2024-03-28
View on ClinicalTrials.gov ↗

Amendment history

2024-04-05
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2024-04-02
minor
Study Status v3
Start date2024-03→2024-03-28
2024-02-23
minor
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v2
Primary completion date2025-05→2027-09
Completion date2025-05→2027-09
Start date2023-10→2024-03
Eligibility criteria+539 characters
Inclusion Criteria: Adult patient (age 18 to 9075 years old) with SpA, meeting the ASAS classification criter [...] ave 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: Patient under legal protection (guardianship Refusal to participate to the study or to sign the informed consentcura [...] [...]
Primary endpoints1 to 2 entries
Increase in gut Metagenome Species Pangenome (MSP) richness in the "intervention" arm. The correctionproportion of dysbiosispatients atsatisfying 6ASAS weeks20 improvement criteria by randomization group
2023-08-25
minor
Study Status v1
Primary completion date2024-07→2025-05
Completion date2024-08→2025-05
Start date2023-01→2023-10
2022-12-08
minor
Original filing
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.
Trial Details
NCT Number NCT05654753
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Fondation Arthritis & Clarins Worldwide 2016
Conditions Axial Spondyloarthritis
Enrollment 20 participants
Start Date 2024-03-28
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2024-04-09