Related Experiment Video
Updated: Nov 7, 2025
Therapeutic Evaluation of Fecal Microbiota Transplantation in an Interleukin 10-Deficient Mouse Model
Published on: April 6, 2022
Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory
Maja Skov Kragsnaes1,2, Jens Kjeldsen3, Hans Christian Horn1
1Rheumatology Research Unit, Department of Rheumatology, Odense University Hospital, Odense, Denmark.
Objectives:
Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA).
Methods:
In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.
Results:
Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)).
Conclusions:
In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA.
Trial Registration Number:
NCT03058900.
Insights
Faecal microbiota transplantation (FMT) did not show efficacy in treating psoriatic arthritis (PsA) and was associated with more treatment failures compared to sham. No serious adverse events were observed in this preliminary trial.
Area of Science:
- Gastroenterology
- Immunology
- Rheumatology
Background:
- Intestinal microbiota dysbiosis is implicated in inflammatory diseases.
- Faecal microbiota transplantation (FMT) is a potential therapeutic strategy for inflammatory conditions.
- Psoriatic arthritis (PsA) is an immune-mediated inflammatory disease affecting joints.
Purpose of the Study:
- To evaluate the safety and efficacy of FMT in patients with active peripheral PsA.
- To explore FMT as a novel treatment for PsA.
- To conduct a proof-of-concept, randomized controlled trial of FMT in PsA.
Main Methods:
- A double-blind, placebo-controlled, superiority trial involving adults with active peripheral PsA.
- Participants received either FMT or a sham transplantation via gastroscopic-guided duodenal infusion.
- Primary endpoint was treatment failure at 26 weeks; secondary endpoints included HAQ-DI and ACR20 response.
Main Results:
- No serious adverse events were reported.
- Treatment failure occurred significantly more often in the FMT group (60%) compared to the sham group (19%).
- The sham group showed greater improvement in HAQ-DI, and no significant difference in ACR20 response was observed between groups.
Conclusions:
- FMT was not found to be superior to sham transplantation in treating active peripheral PsA.
- The study suggests FMT may be inferior to sham in this patient population.
- This preliminary trial did not identify serious safety concerns with FMT in PsA.
Related Concept Videos
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF