Actively Recruiting
Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
Led by Alexandria University · Updated on 2025-09-11
24
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
A
Alexandria University
Lead Sponsor
C
Cairo University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients with chronic plaque psoriasis.
You will not qualify if you...
- Psoriatic patients who used systemic treatments at least 3 months before the study, except acetritin use in the last 3 years.
- Patients with skin infections or other autoimmune diseases such as SLE, lichen planus, dermatomyositis, or vitiligo.
- Pregnant or lactating mothers.
- Patients with any contraindication to methotrexate treatment.
- Patients who develop adverse reactions during methotrexate treatment requiring stopping before 16 weeks, like bone marrow suppression, elevated liver enzymes, or severe gastrointestinal upset.
- Patients with low intellectual capacity, uneducated, or unable/unwilling to provide daily compliance feedback about probiotics.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Research Institute, Alexandria University
Alexandria, Egypt, 21561
Actively Recruiting
Research Team
A
Aliaa G. Aboulela, PhD
CONTACT
E
Eman M. Eleryan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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