What is this trial studying about probiotics and methotrexate for psoriasis?

This trial is studying whether adding probiotics to methotrexate treatment improves the reduction of psoriasis severity and positively affects gut bacteria in adults with newly diagnosed chronic plaque psoriasis. Researchers want to understand how probiotics impact both the disease and gut microbiome compared to methotrexate alone. The study is sponsored by Alexandria University.

Who may be eligible for this psoriasis clinical trial?

Adults aged 18 years or older with newly diagnosed chronic plaque psoriasis may be eligible. The trial includes all genders but excludes those who recently used systemic treatments for psoriasis except acetritin, people with other autoimmune skin diseases, pregnant or breastfeeding women, and those unable to provide daily feedback. Please review eligibility criteria for more details.

Is there any cost to participate in this psoriasis clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Participants may have personal travel expenses that vary and are not guaranteed to be covered by the study.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID07169019

Study of Probiotics and Methotrexate Effects on Gut Health and Symptoms in Adults Newly Diagnosed with Psoriasis

Led by Alexandria University · Updated on 2025-09-11

Participants Needed

Research Sites

18 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether taking probiotics alongside methotrexate can improve treatment response and gut health in adults newly diagnosed with chronic plaque psoriasis. This early phase 1 clinical trial compares the effects of methotrexate alone to methotrexate combined with probiotics, aiming to see if probiotics enhance the reduction of psoriasis severity and positively change the gut microbiome. Participants will be randomly assigned to one of two groups one receiving a weekly oral dose of methotrexate 15-25 mg plus a daily oral dose of probiotics, and the other receiving methotrexate alone on the same weekly schedule. Treatment lasts for 4 months, during which stool samples are collected at the start and after 16 weeks to analyze changes in gut bacteria using advanced DNA sequencing techniques. During the study, participants will visit the clinic after 1 and 2 weeks of starting treatment, then every 4 weeks for checkups and tests. Researchers will collect clinical data including the Psoriasis Activity and Severity Index PASI score monthly, along with blood tests to monitor safety. Participants will provide daily feedback on probiotic and dietary intake. The primary outcome is to assess changes in the gut microbiome and clinical impact over one year, with statistical analysis comparing both treatment groups.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

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 skin or autoimmune diseases such as SLE, Lichen planus, Dermatomyositis, and 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, such as bone marrow suppression, elevated liver enzymes, or severe gastrointestinal upset.
Patients with low intellectual capacity, uneducated patients, or those unable or unwilling to provide daily feedback about probiotic treatment compliance.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 16 weeks

Participants receive weekly oral methotrexate 15-25 mg/week, with or without a daily oral dose of probiotics, to assess changes in gut microbiome and clinical impact on psoriasis.

Weekly visits for treatment and monthly clinical assessments

Follow-up

Duration - Up to 1 year from treatment start

Participants are assessed for gut microbiome changes and clinical outcomes after completing treatment.

Monthly visits for monitoring during and after treatment