Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study

Summary

The goal of this clinical trial is to learn if probiotics work to improve the response of psoriatic patients to methotrexate treatment in adults. It will also learn about the beneficial effect of probiotics on the gut microbiota of psoriatic patients treated with methotrexate. The main questions it aims to answer are: Do probiotics enhance the reduction of disease burden in psoriatic patients under methotrexate treatment? Do probiotics increase the beneficial gut bacteria and decrease the harmful gut bacteria in psoriatic patients under methotrexate treatment? Researchers will compare probiotics intake along with methotrexate to methotrexate alone to see if probiotics work to enhance the reduction of the severity of psoriasis in patients treated by methotrexate and whether the addition of probiotics will improve their gut health. Participants will: Take a daily dose of probiotics with a weekly dose of methotrexate or only a weekly dose of methotrexate for 4 months. Give daily feedback to the researchers about their probiotic intake and their dietary intake. Visit the clinic after 1 and 2 weeks of beginning treatment and then once every 4 weeks for checkups and tests.

Timeline

Start

2025-08-01

Primary completion

2026-08-20

Completion

2026-12-30

Publications

• Results Mu Q, Kirby J, Reilly CM, Luo XM. Leaky Gut As a Danger Signal for Autoimmune Diseases. Front Immunol. 2017 May 23;8:598. doi: 10.3389/fimmu.2017.00598. eCollection 2017.
• Results Strati F, Lattanzi G, Amoroso C, Facciotti F. Microbiota-targeted therapies in inflammation resolution. Semin Immunol. 2022 Jan;59:101599. doi: 10.1016/j.smim.2022.101599. Epub 2022 Mar 15.
• Results Celoria V, Rosset F, Pala V, Dapavo P, Ribero S, Quaglino P, Mastorino L. The Skin Microbiome and Its Role in Psoriasis: A Review. Psoriasis (Auckl). 2023 Oct 26;13:71-78. doi: 10.2147/PTT.S328439. eCollection 2023.
• Results Navarro-Lopez V, Martinez-Andres A, Ramirez-Bosca A, Ruzafa-Costas B, Nunez-Delegido E, Carrion-Gutierrez MA, Prieto-Merino D, Codoner-Cortes F, Ramon-Vidal D, Genoves-Martinez S, Chenoll-Cuadros E, Perez-Orquin JM, Pico-Monllor JA, Chumillas-Lidon S. Efficacy and Safety of Oral Administration of a Mixture of Probiotic Strains in Patients with Psoriasis: A Randomized Controlled Clinical Trial. Acta Derm Venereol. 2019 Nov 1;99(12):1078-1084. doi: 10.2340/00015555-3305.
• Results Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.
• Results Brenchley JM, Douek DC. Microbial translocation across the GI tract. Annu Rev Immunol. 2012;30:149-73. doi: 10.1146/annurev-immunol-020711-075001. Epub 2012 Jan 3.
• Results Reali E, Caliceti C, Lorenzini A, Rizzo P. The Use of Microbial Modifying Therapies to Prevent Psoriasis Exacerbation and Associated Cardiovascular Comorbidity. Inflammation. 2024 Feb;47(1):13-29. doi: 10.1007/s10753-023-01915-1. Epub 2023 Nov 13.
• Results Polak K, Bergler-Czop B, Szczepanek M, Wojciechowska K, Fratczak A, Kiss N. Psoriasis and Gut Microbiome-Current State of Art. Int J Mol Sci. 2021 Apr 26;22(9):4529. doi: 10.3390/ijms22094529.
• Results Vicic M, Kastelan M, Brajac I, Sotosek V, Massari LP. Current Concepts of Psoriasis Immunopathogenesis. Int J Mol Sci. 2021 Oct 26;22(21):11574. doi: 10.3390/ijms222111574.

Drugs

Indications