Efficacy and safety of probiotic supplementation in PsA-a randomized controlled trial.
9 affiliations
- 1Department of Rheumatology and Immunology, Medical University of Graz, Graz, Austria.
- 2Division of Immunology, Otto Loewi research Center, Medical University of Graz, Graz, Austria.
- 3Joint Microbiome Facility, University of Vienna, Vienna, Austria.
- 4Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.
- 5Department of Microbiology and Ecosystem Science, Centre for Microbiology and Environmental Systems Science, University of Vienna, Vienna, Austria.
- 6Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
- 7Center for Biomarker Research in Medicine (CBmed), Graz, Austria.
- 8Department of Physiology & Pathophysiology, Otto Loewi Research Center for Vascular Biology, Immunology, and Inflammation, Medical University of Graz, Graz, Austria.
- 9Department of Rheumatology and Clinical Immunology, Medical Center-University of Freiburg, Faculty of Medicine, Freiburg, Germany.
Abstract
Objectives
To evaluate the clinical efficacy and safety of a multispecies probiotic in patients with 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 <5.4) on stable immunomodulatory therapy were randomized 1:1 to receive either a multispecies (Lactobacillus, Bifidobacterium) probiotic or placebo for 12 weeks. The primary outcome was treatment response at week 12, defined as achieving low disease activity or remission (PASDAS ≤3.2) without treatment change. Secondary outcomes included gut permeability markers, immune cell and microbiome composition. Analyses were conducted per a modified intention-to-treat (only complete cases for primary outcome), with sensitivity analyses using multiple imputation, per-protocol datasets and qPCR-based detection of the probiotic strains in stool (adherence).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 0.13-1.18). 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 the 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.
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BibTeX
@article{bosch2026efficacy,
title = {{Efficacy and safety of probiotic supplementation in PsA-a randomized controlled trial.}},
author = {Philipp Bosch and Angelika Lackner and Barbara Dreo and Johannes Fessler and Florentine Moazedi-Fürst and Rusmir Husic and Joana Séneca and Andreas Haidmayer and Vanessa Stadlbauer and Anirudh Subramanian Muralikrishnan and Jens Thiel and Martin Stradner},
journal = {Rheumatology (Oxford, England)},
year = {2026},
month = oct,
doi = {10.1093/rheumatology/keag547},
url = {https://europepmc.org/article/MED/42832303},
note = {CC BY},
}
RIS
TY - JOUR
TI - Efficacy and safety of probiotic supplementation in PsA-a randomized controlled trial.
AU - Philipp Bosch
AU - Angelika Lackner
AU - Barbara Dreo
AU - Johannes Fessler
AU - Florentine Moazedi-Fürst
AU - Rusmir Husic
AU - Joana Séneca
AU - Andreas Haidmayer
AU - Vanessa Stadlbauer
AU - Anirudh Subramanian Muralikrishnan
AU - Jens Thiel
AU - Martin Stradner
PY - 2026
DA - 2026/10/01
JO - Rheumatology (Oxford, England)
DO - 10.1093/rheumatology/keag547
UR - https://europepmc.org/article/MED/42832303
AB - Objectives To evaluate the clinical efficacy and safety of a multispecies probiotic in patients with 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 <5.4) on stable immunomodulatory therapy were randomized 1:1 to receive either a multispecies (Lactobacillus, Bifidobacterium) probiotic or placebo for 12 weeks. The primary outcome was treatment response at week 12, defined as achieving low disease activity or remission (PASDAS ≤3.2) without treatment change. Secondary outcomes included gut permeability markers, immune cell and microbiome composition. Analyses were conducted per a modified intention-to-treat (only complete cases for primary outcome), with sensitivity analyses using multiple imputation, per-protocol datasets and qPCR-based detection of the probiotic strains in stool (adherence).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 0.13-1.18). 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 the 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.
SN - 1462-0324
SN - 1462-0332
ER -