Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis
NCT ID: NCT03058900
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2017-05-16
2020-06-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fecal microbiota transplantation (FMT)
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.
Methotrexate (MTX)
Weekly methotrexate in maximum tolerable dosis
Placebo (saline)
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.
Methotrexate (MTX)
Weekly methotrexate in maximum tolerable dosis
Interventions
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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.
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.
Methotrexate (MTX)
Weekly methotrexate in maximum tolerable dosis
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Region of Southern Denmark
OTHER
University of Southern Denmark
OTHER
The Danish Rheumatism Association
OTHER
Odense Patient Data Explorative Network
OTHER
The Psoriasis Association, Denmark
UNKNOWN
Manufacturer Vilhelm Pedersen Foundation
OTHER
The Danish Regions (Medicinpuljen)
UNKNOWN
Odense University Hospital
OTHER
Responsible Party
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Torkell Ellingsen
Clinical professor/Head of research and chief consultant MD PhD
Principal Investigators
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Torkell J. Ellingsen, Prof PhD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Dept. of Rheumatology at Odense University Hospital
Odense, , Denmark
Diagnostic Centre at Silkeborg Regional Hospital
Silkeborg, , Denmark
Countries
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References
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Other Identifiers
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OUH-DC-FLORA-01
Identifier Type: -
Identifier Source: org_study_id