Actively Recruiting
The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-04-09
20
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
F
Fondation Arthritis & Clarins Worldwide 2016
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 75 years with axial spondyloarthritis meeting ASAS classification criteria
- Presence or absence of radiographic sacroiliitis (ankylosing spondylitis)
- Active SpA with BASDAI score 4 or higher and back pain score 4 or higher despite optimal drug treatment for at least 6 months
- Previous treatment includes at least two different NSAIDs at maximum tolerated doses and one first-line biologic therapy for at least 4 months
- Stable doses of NSAIDs, sulfasalazine (up to 3 g/day), methotrexate (up to 25 mg/week), hydroxychloroquine (up to 400 mg/day), or oral corticosteroids (up to 10 mg/day prednisone) for at least 4 weeks before baseline
- Stable doses of anti-TNFα, anti-IL-17, or JAK inhibitor therapies for at least 3 months before baseline
- Women of childbearing potential must use effective contraception during inclusion and up to day 168
- Patient must have health insurance (except AME)
- Willingness to provide written informed consent and comply with study protocol
You will not qualify if you...
- Under legal protection such as guardianship or curatorship
- Unlikely to comply or cooperate due to language or mental development issues
- Pregnant or breastfeeding women
- Active inflammatory bowel disease (IBD) as assessed by investigator
- Corticosteroid injection within 4 weeks before inclusion
- Active infection as judged by investigator
- Antibiotic or antifungal treatment within 4 weeks before inclusion
- Probiotic use within 4 weeks before inclusion
- Known Clostridioides difficile or Escherichia coli infection within 10 days before inclusion
- Unstable severe conditions other than axial SpA jeopardizing treatment or evaluation
- Previous fecal microbiota transplantation
- Contraindication to colon preparation (Moviprep or Moviprep orange)
- Current or past bowel obstruction, intestinal ischemia, toxic megacolon, gastrointestinal perforation
- Extensive colectomy (more than two-thirds of colon)
- Gastrointestinal bleeding within past 3 months
- Gastrointestinal surgery within past 3 months
- Severe organ dysfunction
- Contraindication to swallowing capsules
- Known allergy or intolerance to investigational medicinal product or excipients
- Lack of access to a refrigerator to store medication
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rheumatology Department, Ambroise Paré hospital - APHP
Boulogne-Billancourt, France, 92100
Actively Recruiting
Research Team
M
Maxime Breban, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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