Probiotics plus methotrexate in early psoriasis
Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study
This test will see if taking daily probiotics along with weekly methotrexate helps adults with newly diagnosed psoriasis have better skin outcomes and healthier gut bacteria than taking methotrexate alone.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07169019 on ClinicalTrials.gov |
What this trial studies
Adults with newly diagnosed chronic plaque psoriasis will receive weekly methotrexate for four months, with one group also taking a daily probiotic while the other group receives methotrexate alone. Researchers will collect PASI scores at baseline and monthly, monitor bloodwork (CBC, liver and renal function) regularly, and collect stool samples to profile the gut microbiome. The trial compares changes in disease severity and shifts in beneficial or harmful gut bacteria between the two approaches. As an early-phase pilot, it is designed to provide safety data and preliminary signals of clinical and microbiome effects rather than definitive efficacy.
Who should consider this trial
Good fit: Adults with newly diagnosed chronic plaque psoriasis who have not used recent systemic psoriasis treatments and who can comply with daily probiotic use and follow-up visits are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have contraindications to methotrexate, other active autoimmune or skin diseases, recent systemic therapy, or inability to comply with daily reporting are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding probiotics could reduce psoriasis severity and improve gut microbiome health during methotrexate treatment.
How similar studies have performed: Small prior studies suggest probiotics can alter the gut microbiome and may modestly improve psoriasis, but evidence remains limited and inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alexandria
- Medical Research Institute, Alexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed A. Alqasem, MSc — Medical Research Institute, Alexandria University
- Study coordinator: Aliaa G. Aboulela, PhD
- Email: aliaagamaleldin@alexu.edu.eg
- Phone: +201002104138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.