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Trial record 25 of 92 for:    Recruiting Studies | fecal microbiota transplantation

Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis (FLORA)

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ClinicalTrials.gov Identifier: NCT03058900
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
Region of Southern Denmark
University of Southern Denmark
The Danish Rheumatism Association
Odense Patient Data Explorative Network
The Psoriasis Association, Denmark
Manufacturer Vilhelm Pedersen Foundation
The Danish Regions (Medicinpuljen)
Information provided by (Responsible Party):
Torkell Ellingsen, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date January 4, 2019
Actual Study Start Date  ICMJE May 16, 2017
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
Treatment failure [ Time Frame: 6 months (+/- 14 days) ]
Proportion of patients in each group who experience treatment failure according to shared decision making between patient and rheumatologist defined as at least one of the following:
  • Need for more than 1 intra-articular glucocorticoid injection due to disease activity.
  • Need for change to other conventional DMARDs (at the moment oral leflunomide, sulfasalazin or ciclosporin) according to the updated Danish guideline treatment due to disease activity.
  • Need for biologic treatment according to the updated Danish guideline treatment due to severe disease activity.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03058900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • The Short Health Assessment Questionnaire (2-page HAQ) [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in the Short Health Assessment Questionnaire (2-page HAQ).
  • The Dermatology Life Quality Index (DLQI) Questionnaire [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in the Dermatology Life Quality Index (DLQI).
  • Patient Reported Gastrointestinal Side Effects [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in gastrointestinal symptoms.
  • Patient Reported Other Side Effects [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in other (non-gastrointestinal) symptoms.
  • The American College of Rheumatology (ACR) Response Criteria [ Time Frame: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Proportion of patients in each group achieving
    • ACR20 response criteria
    • ACR50 response criteria
    • ACR70 response criteria
    A patient will be considered as improved according to the ACR20/50/70 response criteria if she/he has at least 20/50/70% improvement in the two following measures: Tender joint count (68) and swollen joint count (66), and at least 3 of the following 5 measures: Patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ) score, acute phase reactant (CRP).
  • The Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Proportion of patients in each group achieving PsARC response criteria. A patient will be considered as improved according to the PsARC response criteria if she/he has an improvement in either joint swelling or tenderness, and in any of 4 other measures: Patient global assessment of articular disease; physician global assessment of articular disease; joint pain or tenderness; joint swelling.
  • The Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [ Time Frame: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in SPARCC Enthesitis Index in the subset of patients who have enthesitis at baseline.
  • The Psoriasis Area Severity Index (PASI) [ Time Frame: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in the Psoriasis Area Severity Index (PASI) in the subset of patients who have psoriasis at baseline.
  • Dactylitis [ Time Frame: Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days) ]
    Change from baseline in the number of digits affected with dactylitis in the subset of patients who have dactylitis at baseline.
  • Number of Adverse Events [ Time Frame: 6 months (+/- 14 days) ]
    Number of adverse events in each group.
  • Number of Patients with Adverse Events [ Time Frame: 6 months (+/- 14 days) ]
    Number of patients with at least one adverse event in each group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis
Official Title  ICMJE Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Peripheral Psoriatic Arthritis: a 6-month, Double-Blind, Randomized, Placebo-Controlled Trial
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Double-Blind
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: Fecal microbiota transplantation (FMT)
    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.
  • Other: Drug: Placebo (saline)
    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.
  • Drug: Methotrexate (MTX)
    Weekly methotrexate in maximum tolerable dosis
Study Arms  ICMJE
  • Experimental: Fecal microbiota transplantation (FMT)
    Interventions:
    • Drug: Fecal microbiota transplantation (FMT)
    • Drug: Methotrexate (MTX)
  • Sham Comparator: Placebo (saline)
    Interventions:
    • Other: Drug: Placebo (saline)
    • Drug: Methotrexate (MTX)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Torkell J. Ellingsen, Prof PhD +45 22397306 torkell.ellingsen@rsyd.dk
Contact: Maja S. Kragsnaes, MD +45 22982528 maja.kragsnaes@dadlnet.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03058900
Other Study ID Numbers  ICMJE OUH-DC-FLORA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Torkell Ellingsen, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Region of Southern Denmark
  • University of Southern Denmark
  • The Danish Rheumatism Association
  • Odense Patient Data Explorative Network
  • The Psoriasis Association, Denmark
  • Manufacturer Vilhelm Pedersen Foundation
  • The Danish Regions (Medicinpuljen)
Investigators  ICMJE
Principal Investigator: Torkell J. Ellingsen, Prof PhD Odense University Hospital
PRS Account Odense University Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP