Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
Recruiting · NCT07169019 · Interventional (participants receive a specific treatment) · Lead sponsor: Alexandria University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Newly diagnosed patients with chronic plaque psoriasis.
Exclusion criteria
- • 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.
Where it is running
1 location listed.
- Medical Research Institute, Alexandria University - Alexandria, Egypt