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

NCT ID: NCT07169019

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-30

Brief 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.

Detailed Description

This study aims to identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard first line treatment with methotrexate alone.

Methods

1. Collection of demographic and clinical data:

• Data about the full medical history will be collected for all patients (including name, age, sex, history of the disease, duration of illness, association with other autoimmune diseases like vitiligo, diabetes type 1, etc).
• Data about the results of full clinical examination of all patients will be collected.
• Data about the clinical assessment of the severity of Psoriasis will be collected as indicated by the Psoriasis Activity and Severity Index (PASI) score (which is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance). PASI score will be calculated before treatment and every month during treatment. (Appendix 1)
• Data about base line pretreatment laboratory investigations will be collected: CBC, liver and renal function test.
• Data about follow up lab investigations will be collected:

• CBC at week 2 and week 4 after treatment and every month thereafter.
• Liver function tests at week 2 after treatment and every month thereafter.
• Renal function tests at week 1 after treatment and every month thereafter.

2. Stool samples will be collected from every participant at baseline (before the start of treatment) and at the end of the 16th week of treatment (at the efficacy of treatment assessment visit). Samples will be stored in sterile screw-capped tubes, and kept at -80 ºC, till the time of subsequent experiments.

3. Total DNA will be isolated from stool samples using QIAamp DNA Stool Mini Kit following the manufacturer's instructions.

4. Illumina Next generation sequencing: The microbiota composition will be determined by amplification of the V3 and V4 hypervariable regions of the 16S rRNA gene using universal primers with Illumina compatible adaptors.

• 16S Metagenomic Sequencing Library will be prepared according to the Illumina Protocol.
• Bioinformatic analysis of 16S rRNA amplicon sequencing data will be performed for classification of reads at taxonomic levels.

5. Changes in microbiome profiles of participants will be determined and correlated with the clinical outcome of treatment.

6. Statistical analysis: The obtained results from the cases the controls will be statistically analyzed using the appropriate statistical methods.

Conditions

Psoriasis (PsO)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Probiotics and methotrexate group

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

Group Type: EXPERIMENTAL

Probiotics and methotrexate

Intervention Type: DRUG

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

Methotrexate group

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

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

weekly oral methotrexate 15-25 mg/week

Interventions

Probiotics and methotrexate

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

Intervention Type: DRUG

Methotrexate

weekly oral methotrexate 15-25 mg/week

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Aliaa Gamaleldin Aboulela

Associate Professor of Microbiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ezzeldin A. Saleh, PhD

Role: STUDY_CHAIR

Medical Research Institute, Alexandria University

Gamaleldin A. Elsawaf, PhD

Role: STUDY_DIRECTOR

Medical Research Institute, Alexandria University

Mohamed A. Alqasem, MSc

Role: PRINCIPAL_INVESTIGATOR

Medical Research Institute, Alexandria University

Locations

Medical Research Institute, Alexandria University

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aliaa G. Aboulela, PhD

Role: CONTACT

aliaagamaleldin@alexu.edu.eg

+201002104138

Eman M. Eleryan, MD

Role: CONTACT

eman.elaryan@alexmed.edu.eg

+201001538935

Facility Contacts

Aliaa G. Aboulela, PhD

Role: primary

aliaagamaleldin@alexu.edu.eg

+201002104138

Eman M. Eleryan., MD.

Role: backup

eman.elaryan@alexmed.edu.eg

+201001538935

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Other Identifiers

E/C. S/N. T24/2025

Identifier Type: -

Identifier Source: org_study_id