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

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          Abstract

          Introduction

          An 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 analysis

          This 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 dissemination

          This 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.

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          Most cited references 95

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          The microbiome and innate immunity.

          The intestinal microbiome is a signalling hub that integrates environmental inputs, such as diet, with genetic and immune signals to affect the host's metabolism, immunity and response to infection. The haematopoietic and non-haematopoietic cells of the innate immune system are located strategically at the host-microbiome interface. These cells have the ability to sense microorganisms or their metabolic products and to translate the signals into host physiological responses and the regulation of microbial ecology. Aberrations in the communication between the innate immune system and the gut microbiota might contribute to complex diseases.
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            Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.

            Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.
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              Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.

              The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                27 April 2018
                : 8
                : 4
                Affiliations
                [1 ] departmentDepartment of Rheumatology , Odense University Hospital , Odense, Denmark
                [2 ] departmentOdense Patient data Explorative Network (OPEN), Department of Clinical Institute , University of Southern Denmark , Odense, Denmark
                [3 ] departmentDepartment of Gastroenterology , Odense University Hospital , Odense, Denmark
                [4 ] departmentDepartment of Clinical Microbiology , Odense University Hospital , Odense, Denmark
                [5 ] departmentDepartment of Clinical Immunology , Odense University Hospital , Odense, Denmark
                [6 ] departmentDiagnostic Centre , Silkeborg Regional Hospital , Silkeborg, Denmark
                [7 ] departmentIRS-Centre Sonderjylland , Hospital of Southern Jutland , Aabenraa, Denmark
                [8 ] departmentInstitute of Molecular Medicine , University of Southern Denmark , Odense, Denmark
                [9 ] departmentLaboratory of Genomics and Molecular Biomedicine, Department of Biology , University of Copenhagen , Copenhagen, Denmark
                [10 ] departmentInstitute of Metagenomics , BGI-Shenzhen , Shenzhen, China
                [11 ] departmentMusculoskeletal Statistics Unit, Parker Institute , Frederiksberg and Bispebjerg Hospital , Copenhagen, Denmark
                Author notes
                [Correspondence to ] Maja Skov Kragsnaes; maja.kragsnaes@ 123456dadlnet.dk
                Article
                bmjopen-2017-019231
                10.1136/bmjopen-2017-019231
                5922473
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                Product
                Funding
                Funded by: Odense Patient Explorative data Network (OPEN);
                Funded by: University of Southern Denmark;
                Funded by: the Danish Psoriasis Research Fund;
                Funded by: Fabrikant Vilhelm Pedersen and Hustrus Legat based on the recommendation of the Novo Nordisk Foundation;
                Funded by: Region of Southern Denmark;
                Funded by: the Danish Regions;
                Funded by: the Danish Rheumatism Association;
                Funded by: Odense University Hospital;
                Categories
                Rheumatology
                Protocol
                1506
                1732
                1468
                Custom metadata
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