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Taking people in EgyptEarly phase 1

Probiotics with methotrexate tested in newly diagnosed psoriasis patients

Tests whether probiotics added to methotrexate help adults with newly diagnosed psoriasis.

Key facts

Who runs it
Alexandria University
Where
Alexandria, EgyptSee the site
Trial code
Registry title
Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
Status
Recruiting
Phase
Early phase 1
People taking part
24 people, planned
Started
1 Aug 2025
Expected to end
30 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Probiotics and methotrexate
  • Methotrexate
Record updated
11 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who were recently diagnosed with chronic plaque psoriasis. It tests whether probiotics added to methotrexate help.

Age
18 years or older
Sex
Women and men can join.
Disease stage
Newly diagnosed chronic plaque psoriasis.
Earlier treatment
People who used systemic treatments for psoriasis in the last 3 months before the study cannot join, except acitretin use in the last 3 years.

Main reasons for not taking part

  • Skin infection, or another skin or autoimmune disease such as SLE, Lichen planus, Dermatomyositis or Vitiligo
  • Pregnant or breastfeeding women
  • Any reason that rules out methotrexate treatment
  • Unable or unwilling to give daily feedback on taking the probiotics
  • Low intellectual capacity or no education

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Newly diagnosed patients with chronic plaque psoriasis

Who cannot take part

  • • 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 in Egypt

  • Medical Research Institute, Alexandria UniversityAlexandria, EgyptContact: Aliaa G. Aboulela, PhDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Probiotics and methotrexate groupTreatment being tested

    Patients will receive weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics.

    Treatment: Probiotics and methotrexate

  • Methotrexate groupExisting treatment, for comparison

    Patients will receive weekly oral methotrexate 15-25 mg/week.

    Treatment: Methotrexate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study
Plain-language title
Probiotics with methotrexate tested in newly diagnosed psoriasis patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 September 2025