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Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis

NCT03058900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-12-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • The Danish Rheumatism Association

    collaborator OTHER

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • The Psoriasis Association, Denmark

    collaborator UNKNOWN

  • Manufacturer Vilhelm Pedersen Foundation

    collaborator OTHER

  • The Danish Regions (Medicinpuljen)

    collaborator UNKNOWN

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Torkell J. Ellingsen, Prof PhD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-16
Primary Completion
2020-06-02
Completion
2020-06-02

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058900 on ClinicalTrials.gov