BridgeMD
Fecal Microbiota Transplantation Trial in Axial Spondyloarthritis
EU CTIS ID: 2023-504852-89-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient (age 18 to 75 years old) with SpA diagnosed for at least 6 months at the time of inclusion, 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 current treatment, having a BASDAI score ≥ 4 (0-10) 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) or JAK inhibitor for at least 4 months (or less in case of intolerance or contra-indication)
- Subjects are allowed to continue oral NSAID, oral and/or subcutaneus methotrexate (≤ 25 mg/week) and/or oral hydroxychloroquine (≤ 400 mg/day) and/or oral corticosteroid (≤ 10 mg/day of prednisone), as long as these treatments have remained at stable dose (i.e. inchanged dose) for 4 weeks prior to inclusion
- Subjects are allowed to continue anti-TNFα, anti-IL-17 or JAK inhibitor therapies, as long as these treatments have remained at stable dose for 3 months prior to inclusion
- 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)
You likely can't join if
- Patient under legal protection (guardianship or curatorship)
- 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
See the full eligibility criteria
Who can join
- Adult patient (age 18 to 75 years old) with SpA diagnosed for at least 6 months at the time of inclusion, 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 current treatment, having a BASDAI score ≥ 4 (0-10) 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) or JAK inhibitor for at least 4 months (or less in case of intolerance or contra-indication)
- Subjects are allowed to continue oral NSAID, oral and/or subcutaneus methotrexate (≤ 25 mg/week) and/or oral hydroxychloroquine (≤ 400 mg/day) and/or oral corticosteroid (≤ 10 mg/day of prednisone), as long as these treatments have remained at stable dose (i.e. inchanged dose) for 4 weeks prior to inclusion
- Subjects are allowed to continue anti-TNFα, anti-IL-17 or JAK inhibitor therapies, as long as these treatments have remained at stable dose for 3 months prior to inclusion
- 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
What rules you out
- Patient under legal protection (guardianship or curatorship)
- 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
- 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
- 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
- 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 Clostridium difficile or Escherichia coli within 10 days before inclusion
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.