Efficacy and safety of faecal microbiota transplantation in patients with psoriatic arthritis: protocol for a 6-month, double-blind, randomised, placebo-controlled trial

• Published in: BMJ open 2018-04, Vol.8 (4), p.e019231-e019231
• Main Authors: Kragsnaes, Maja Skov, Kjeldsen, Jens, Horn, Hans Christian, Munk, Heidi Lausten, Pedersen, Finn Moeller, Holt, Hanne Marie, Pedersen, Jens Kristian, Holm, Dorte Kinggaard, Glerup, Henning, Andersen, Vibeke, Fredberg, Ulrich, Kristiansen, Karsten, Christensen, Robin, Ellingsen, Torkell
• Format: Article
• Language: English
• Subjects: Antigens; Bacteria; Disease; Double-blind studies; Evidence-based medicine; Feces; Immunology; Infections; Inflammation; Inflammatory bowel disease; Microbiota; Pathogenesis; Probiotics; Psoriasis; Psoriatic arthritis; Rheumatic diseases; Rheumatoid arthritis; Rheumatology; Science; Skin; Transplants & implants; Tumor necrosis factor-TNF; Viral infections
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-019231

IntroductionAn unbalanced intestinal microbiota may mediate activation of the inflammatory pathways seen in psoriatic arthritis (PsA). A randomised, placebo-controlled trial of faecal microbiota transplantation (FMT) infused into the small intestine of patients with PsA with active peripheral disease who are non-responsive to methotrexate (MTX) treatment will be conducted. The objective is to explore clinical aspects associated with FMT performed in patients with PsA.Methods and analysisThis trial is a randomised, two-centre stratified, double-blind (patient, care provider and outcome assessor), placebo-controlled, parallel-group study. Eighty patients will be included and randomised (1:1) to either placebo (saline) or FMT provided from an anonymous healthy donor. Throughout the study, both groups will continue the weekly self-administered subcutaneous MTX treatment, remaining on the preinclusion dosage (15–25 mg/week). The clinical measures of psoriasis and PsA disease activity used include the Short (2-page) Health Assessment Questionnaire, the Dermatology Quality of Life Index, the Spondyloarthritis Research Consortium of Canada Enthesitis Index, the Psoriasis Area Severity Index, a dactylitis digit count, a swollen/tender joint count (66/68), plasma C reactive protein as well as visual analogue scales for pain, fatigue and patient and physician global assessments. The primary end point is the proportion of patients who experience treatment failure during the 6-month trial period. The number of adverse events will be registered throughout the study.Ethics and disseminationThis is a proof-of-concept clinical trial and will be performed in agreement with Good Clinical Practice standards. Approvals have been obtained from the local Ethics Committee (DK-S-20150080) and the Danish Data Protection Agency (15/41684). The study has commenced in May 2017. Dissemination will be through presentations at national and international conferences and through publications in international peer-reviewed journal(s).Trial registration number NCT03058900; Pre-results.