A Phase 2/3 interventional study of active FMT and Placebo in Axial Spondyloarthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Treatment
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:
Axial spondyloarthritis (SpA) is a chronic inflammatory disease primarily affecting the sacroiliac and spinal joints that usually begins in young adults and is a major cause of chronic pain and disability that profoundly alter the quality of life of patients. Besides non-steroidal anti-inflammatory drugs, the development of anti-tumor necrosis factor-α (TNFα) and anti-interleukin (IL-17) biotherapies and of JAK inhibitors, has improved the management of these patients. However only half of the patients respond to these treatments and many of them are only partially relieved. Remarkably, this disorder frequently combines with overt inflammatory bowel disease (IBD) -i.e. Crohn's disease (CD) or ulcerative colitis (UC)- and even more frequently with subclinical gut inflammation, leading to suspect a role of the gut microbiota as a possible trigger. Consistently, recent studies evidenced an alteration of gut microbiota composition -or dysbiosis- in the course of SpA that appeared all the more pronounced that disease was more active. It was notably shown a restriction of bacterial diversity and an expansion of species considered as potentially pro-inflammatory, including Ruminococcus gnavus. Given its potential involvement in the pathogenesis of SpA, gut microbiota could be considéred as a promising therapeutic target. Fecal microbiota transplantation (FMT) is a technic consisting in thorough replacement of dysbiotic microbiota by healthy dondor's microbiota that has recently been developped to correct dysbiosis. It has been validated for the treatment of intractable colitis due to Clostridium difficile and its efficacy has been reported in CD or UC. The current trial, aims to evaluate efficacy of FMT in drug-resistant axial SpA.
207 studies on the registry are indexed under Axial Spondyloarthritis; 57 are open to participants now.
This study's planned enrollment of 20 is below the median of 110 across 140 interventional studies indexed under Axial Spondyloarthritis.
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Exclusion Criteria:
active FMT
Drug: active FMT
placebo
Drug: Placebo
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.
Patients will receive 20 capsules placebo, each containing placebo at once at day 0, then 3 capsules/day from day 1 through day 20.
Increase in gut Metagenome Species Pangenome (MSP) richness in the "intervention" arm.
Fecal microbiota composition will be assessed by thorough microbial DNA sequencing (shotgun) at baseline (anytime between D-4 and D-1) and then at D28, D42, D84 and D168. The success will be evaluated by an increase in gut Metagenome Species Pangenome (MSP) richness over the period of study.
Time frame: at baseline and D 42
The proportion of patients satisfying ASAS 20 improvement criteria by randomization group
ASAS20 is defined by an improvement of ≥ 20% and of ≥ 10 points on a 0-100 numerical scale of 3 of the 4 following domains: global evaluation by the patient (PGA), pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and inflammation (evaluated by the answer to both last questions of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) as well as an absence of deterioration from baseline by ≥ 20% and by ≥ 10 points in the fourth domain. The comparison of ASAS20 scores at D42 between randomization groups will be an exploratory analysis, considering literature data.
Time frame: at D 42
efficacy of FMT
Superior efficacy of FMT over placebo defined by an increase in MSP richness at week 6 in the FMT group, superior to variation in the placebo group
Time frame: week 6
Change of dysbiotic fecal microbiota
To correct dysbiotic fecal microbiota at weeks 3, 12 and 24 in FMT-treated group, by comparison with baseline. Fecal microbiota composition will be assessed by thorough microbial DNA sequencing (shotgun), in a way similar to week 6 in FMT and placebo groups and the variation between baseline and different end-points (weeks 3, 12, 24) will be compared between both arms.
Time frame: at baseline, at weeks 3, 12 and 24
Clinical improvement
Clinical improvement during the 24 weeks follow-up after FMT or sham-FMT. We will compare between both arms the proportion of patients satisfying ASAS20 improvement criteria at weeks 3, 6, 12 and 24 as compared to baseline (week 0). \[ASAS20 is defined by an improvement of at least 20% and of at least 10 points on a 0-100 scale in ≥ 3 of the following 4 domains: global assessment by the patient (PGA), back pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and inflammation (evaluated by the answer to both last questions of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and absence of deterioration in the potential remaing domain, where deterioration is defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 points (on a scale of 0-100)
Time frame: at baseline, weeks 3, 6, 12 and 24
ESR and CRP levels
Improvement of biological inflammation by ESR and CRP levels variation
Time frame: at weeks 3, 6, 12 and 24
CHANGE OF ASDAS_CRP and ASDAS_ESR
Improvement of ASDAS\_CRP and ASDAS\_ESR at weeks 3, 6, 12 and 24
Time frame: at weeks 3, 6, 12 and 24
Change in Bath Ankylosing Spondylitis Metrology Index
Improvement of Bath Ankylosing Spondylitis Metrology Index (BASMI) at weeks 3, 6, 12 and 24
Time frame: at weeks 3, 6, 12 and 24
non-steroidal anti-inflammatory drugs (NSAID) intake
Decrease of non-steroidal anti-inflammatory drugs (NSAID) intake score.
Time frame: through study completion, an average of 18 months
Plan to share: No
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