Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic Arthritis

NCT03058900 | Completed

• 1 other identifier: OUH-DC-FLORA-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriatic Arthritis

Keywords

Fecal Microbiota Transplantation; FMT; Randomized Controlled Trial; Intestinal microbiome; RCT; Faecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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.

  6 months (+/- 14 days)

Secondary Outcomes (11)

• The Short Health Assessment Questionnaire (2-page HAQ)

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

• The Dermatology Life Quality Index (DLQI) Questionnaire

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

• Patient Reported Gastrointestinal Side Effects

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

• Patient Reported Other Side Effects

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months (+/- 7 days), 6 months (+/- 14 days)

• The American College of Rheumatology (ACR) Response Criteria

  Baseline, 3 months (+/- 7 days), 6 months (+/- 14 days)

Study Arms (2)

Fecal microbiota transplantation (FMT)

EXPERIMENTAL

Drug: Fecal microbiota transplantation (FMT); Drug: Methotrexate (MTX)

Placebo (saline)

SHAM COMPARATOR

Other: Drug: Placebo (saline); Drug: Methotrexate (MTX)

Interventions

Fecal microbiota transplantation (FMT) DRUG

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.

Fecal microbiota transplantation (FMT)

Drug: Placebo (saline) OTHER

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.

Placebo (saline)

Methotrexate (MTX) DRUG

Weekly methotrexate in maximum tolerable dosis

Fecal microbiota transplantation (FMT); Placebo (saline)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Not wishing to participate or unsuited for project evaluation.

Sponsors & Collaborators

• Odense University Hospital: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator
• The Danish Rheumatism Association: collaborator
• Odense Patient Data Explorative Network: collaborator
• The Psoriasis Association, Denmark: collaborator
• Manufacturer Vilhelm Pedersen Foundation: collaborator
• The Danish Regions (Medicinpuljen): collaborator

Study Sites (2)

Dept. of Rheumatology at Odense University Hospital

Odense, 5000, Denmark

Location

Diagnostic Centre at Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (27)

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MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Fecal Microbiota Transplantation; Sodium Chloride; Methotrexate

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Torkell J. Ellingsen, Prof PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor/Head of research and chief consultant MD PhD

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: May 16, 2017
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)