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

NCT07169019 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-11

No results posted yet for this 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.

Conditions

  • Psoriasis (PsO)

Interventions

DRUG

Probiotics and methotrexate

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

DRUG

Methotrexate

weekly oral methotrexate 15-25 mg/week

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Alexandria University

    lead OTHER

Principal Investigators

  • Ezzeldin A. Saleh, PhD · Medical Research Institute, Alexandria University

  • Gamaleldin A. Elsawaf, PhD · Medical Research Institute, Alexandria University

  • Mohamed A. Alqasem, MSc · Medical Research Institute, Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-20
Completion
2026-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07169019 on ClinicalTrials.gov