Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      An abnormal intestinal microbiota may be the mediator of the common inflammatory pathways
      seen in psoriatic arthritis. This study will explore clinical aspects associated with
      modifying the intestinal microbiota by infusing fecal donor microbiota into the small
      intestine of psoriatic arthritis patients with a minimum of three swollen joints despite at
      least three months of methotrexate treatment.
    

Detailed description: 
      Recent years have seen growing recognition of the complexity of the role of the microbiota in
      shaping the immune system and its potential effects for health and disease. In particular,
      the gut bacteria composition has been associated with the pathogenesis of autoimmune and
      inflammatory diseases. Intriguingly, presence of intestinal inflammation in psoriatic
      arthritis (PsA) patients has been documented in several studies. Also, in genetically
      predisposed patients reactive arthritis, which share some of the clinical manifestations of
      PsA, can be triggered by certain types of bacterial gut infections. Furthermore, a recent
      study has reported that several intestinal bacteria including Akkermansia and Ruminoccocus,
      which are known to play an important role in maintaining gut homeostasis, were practically
      absent in PsA patients. Mechanisms through which the microbiota may be involved in the
      pathogenesis of PsA include an abnormal activation of the gut-associated lymphoid tissue
      (GALT) and/or an altered mucosal permeability thus compromising the capacity of the intestine
      to provide adequate containment of luminal microorganisms and molecules.

      By conducting a double-blinded, randomized, placebo-controlled trial of a non-related donor
      fecal microbiota transplantation (FMT) infused into the small intestine, this study will
      reveal whether FMT is more effective than an identically appearing placebo (saline) in
      reducing disease activity in psoriatic arthritis patients presenting with a minimum of three
      swollen joints despite at least three months of methotrexate treatment (maximal tolerable
      dosis ≥ 15 mg/week). All patients will throughout the study continue their individual
      treatment with weekly methotrexate.
    

Intervention name(s): Fecal microbiota transplantation (FMT); Drug: Placebo (saline); Methotrexate (MTX)
Intervention type(s): Drug; Other; Drug
Intervention description(s): One fecal microbiota transplantation is performed at baseline using gastroscopic guidance. The transplant consists of 50 g feces obtained from a healthy non-related donor. The donor feces is suspended into NaCl (0.9%) and glycerol (10%), and will be stored at minus 80 degrees celsius until use. The total volume of the suspension is 250 mL and its temperature will be 37 degrees celsius when infused into the small intestine of the recipient.; One identical appearing sham procedure is performed at baseline using gastroscopic guidance. 250 mL saline (NaCl 0.9%) is infused into the small intestine of the recipient.; Weekly methotrexate in maximum tolerable dosis
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fecal Microbiota Transplantation; FMT; Randomized Controlled Trial; Intestinal microbiome; RCT; Faecal microbiota transplantation