Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed patients with chronic plaque psoriasis.

Locations
Other Locations
Egypt
Medical Research Institute, Alexandria University
RECRUITING
Alexandria
Contact Information
Primary
Aliaa G. Aboulela, PhD
aliaagamaleldin@alexu.edu.eg
+201002104138
Backup
Eman M. Eleryan, MD
eman.elaryan@alexmed.edu.eg
+201001538935
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 24
Treatments
Experimental: Probiotics and methotrexate group
Patients will receive weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics.
Active_comparator: Methotrexate group
Patients will receive weekly oral methotrexate 15-25 mg/week.
Related Therapeutic Areas
Sponsors
Collaborators: Cairo University
Leads: Alexandria University

This content was sourced from clinicaltrials.gov