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

NCT07169019 | Recruiting Early Phase 1

• 1 other identifier: E/C. S/N. T24/2025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis (PsO)

Keywords

Psoriasis; gut microbiome; methotrexate; probiotics

Outcome Measures

Primary Outcomes (1)

• To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone.

  The composition of gut microbiota before the start of treatment and after the end of the treatment course will be determined by analysis of a stool sample from each participant by illumina Next generation sequencing and 16S Metagenomics bioinformatics analysis of data to identify microbial taxa in the samples. The clinical impact induced by treatment of newly diagnosed psoriatic patients with probiotics and methotrexate or methotrxate alone will be determined by the calculation of PASI score before and after treatment.

  One year

Study Arms (2)

Probiotics and methotrexate group

EXPERIMENTAL

Patients will receive weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics.

Drug: Probiotics and methotrexate

Methotrexate group

ACTIVE COMPARATOR

Patients will receive weekly oral methotrexate 15-25 mg/week.

Drug: Methotrexate

Interventions

Probiotics and methotrexate DRUG

weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics.

Probiotics and methotrexate group

Methotrexate DRUG

weekly oral methotrexate 15-25 mg/week

Methotrexate group

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed patients with chronic plaque psoriasis.

You may not qualify if:

• Psoriatic patients who used systemic treatments at least 3 months before the study, with the exception of acetritin use, in the last 3 years.
• Patients who have skin infection or other skin or autoimmune diseases such as SLE, Lichen planus, Dermatomyositis and Vitiligo, by history and examination.
• Pregnant or Lactating mothers.
• Patients with any contraindication to methotrexate treatment.
• Patients who develop any adverse reaction during systemic treatment with methotrexate that necessitates cessation of treatment before the 16th week, such as bone marrow suppression as indicated by CBC, elevated liver enzymes, or severe GIT upset.
• Patients with low intellectual capacity, uneducated patients, or patients unable or unwilling to provide daily feedback about their compliance to the provided probiotics treatment.

Sponsors & Collaborators

• Alexandria University: lead
• Cairo University: collaborator

Study Sites (1)

Medical Research Institute, Alexandria University

Alexandria, 21561, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 28588585 RESULT

• 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.

  PMID: 35304068 RESULT

• 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.

  PMID: 37908308 RESULT

• 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.

  PMID: 31453631 RESULT

• 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.

  PMID: 30793796 RESULT

• 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.

  PMID: 22224779 RESULT

• 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.

  PMID: 37953417 RESULT

• 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.

  PMID: 33926088 RESULT

• 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.

  PMID: 34769005 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

Probiotics; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ezzeldin A. Saleh, PhD

  Medical Research Institute, Alexandria University

  STUDY CHAIR

• Gamaleldin A. Elsawaf, PhD

  Medical Research Institute, Alexandria University

  STUDY DIRECTOR

• Mohamed A. Alqasem, MSc

  Medical Research Institute, Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliaa G. Aboulela, PhD

CONTACT

+201002104138; aliaagamaleldin@alexu.edu.eg

Eman M. Eleryan, MD

CONTACT

+201001538935; eman.elaryan@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Microbiology

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

EG (1)