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Tests treatment safety and results for Axial Spondyloarthritis
Official title The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment
ClinicalTrials.gov ID: NCT05654753
What this study is testing
What is active FMT?
active FMT is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for axial spondyloarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult patient (age 18 to 75 years old) with SpA, meeting the ASAS classification criteria for axial SpA, with presence of radiographic sacro-illitis...
- 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...
- people are allowed to continue NSAID, sulfasalazin (≤ 3 g/day) and/or methotrextae ( ≤ 25 mg/week) and/or hydroxychloroquine (≤ 400 mg/day) and/or...
- people 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...
- Women of childbearing potential with efficient contraceptive protection at the inclusion and during at least the treatment phase (D168).
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- people 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...
- people 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 treatment 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.
- 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 treatment clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Boulogne-Billancourt, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulogne-Billancourt, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.