Status:
RECRUITING
Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
Lead Sponsor:
Alexandria University
Collaborating Sponsors:
Cairo University
Conditions:
Psoriasis (PsO)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 prob...
Detailed Description
This study aims 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 ...
Eligibility Criteria
Inclusion
- Newly diagnosed patients with chronic plaque psoriasis.
Exclusion
- • 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07169019
Start Date
August 1 2025
End Date
December 30 2026
Last Update
September 11 2025
Active Locations (1)
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1
Medical Research Institute, Alexandria University
Alexandria, Egypt, 21561