Abstract
Abstract
Objectives
To evaluate the clinical efficacy and safety of a multispecies probiotic in patients with psoriatic arthritis (PsA) in moderate disease activity.
Methods
In this single-centre, randomized, double-blind, placebo-controlled trial (RCT), 66 PsA patients with moderate disease activity (Psoriatic Arthritis Disease Activity Score [PASDAS] >3.2 to
Results
Fifty-six participants were included in the main analysis. Thirteen (43%) participants in the probiotic group and 17 (65%) in the placebo group achieved the primary outcome (p = 0.167). The corresponding odds ratio was 0.4 (95% CI 0.13 to 1.18). Patient-reported pain and global assessment were the main PASDAS components improving over time, with no between-group differences. No differences were observed in secondary clinical outcomes, gut permeability markers (zonulin, calprotectin, alpha-1-antitrypsin), immune cell profiles, or stool microbiome composition between groups at week 12. No serious adverse events related to the study product were reported.
Conclusion
In this first RCT investigating probiotic supplementation in PsA, probiotic treatment did not show superiority over placebo in achieving treatment response, or altering gut microbiome, or permeability.