Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis

NACompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

June 2, 2020

Study Completion Date

June 2, 2020

Conditions
Psoriatic Arthritis
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

Trial Locations (2)

5000

Dept. of Rheumatology at Odense University Hospital, Odense

8600

Diagnostic Centre at Silkeborg Regional Hospital, Silkeborg

All Listed Sponsors
collaborator

Region of Southern Denmark

OTHER

collaborator

University of Southern Denmark

OTHER

collaborator

The Danish Rheumatism Association

OTHER

collaborator

Odense Patient Data Explorative Network

OTHER

collaborator

The Psoriasis Association, Denmark

UNKNOWN

collaborator

Manufacturer Vilhelm Pedersen Foundation

OTHER

collaborator

The Danish Regions (Medicinpuljen)

UNKNOWN

lead

Odense University Hospital

OTHER

NCT03058900 - Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis | Biotech Hunter | Biotech Hunter