Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis

• Status: Completed
• Trial end date: 2020-06-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Collaborators: Manufacturer Vilhelm Pedersen Foundation; Odense Patient Data Explorative Network; Odense Patient Explorative data Network (OPEN); Region of Southern Denmark; The Danish Regions (Medicinpuljen); The Danish Rheumatism Association; The Psoriasis Association, Denmark; University of Southern Denmark
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).

• Presence of active peripheral psoriatic arthritis defined as ≥ 3 swollen joints.

• Methotrexate (≥ 15mg/week (maximal tolerable dosage)) for a minimum of 3 months prior to study inclusion.

Exclusion Criteria:

• Other inflammatory rheumatic diseases than PsA.

• Current axial disease activity or severe peripheral joint activity demanding immediate change of treatment or contraindicating placebo treatment for 6 months.

• History of severe MTX toxicity or allergic reactions.

• Current biological treatment and biological treatment within the last 6 months.

• Inflammatory bowel disease, celiac disease, food allergy, or other intestinal diseases.

• Current cancer or severe chronic infections.

• Pregnant or breastfeeding women.

• Systemic and/or local intra-articular or peritendinous steroid injections within 3 months of inclusion.

• Non-MTX DMARD treatment within three months of inclusion.

• Antibiotics within 3 months of inclusion.

• Not wishing to participate or unsuited for project evaluation.