Leaky Gut As a Danger Signal for Autoimmune Diseases.
Qinghui Mu, Jay Kirby, Christopher M Reilly...
https://pubmed.ncbi.nlm.nih.gov/28588585Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID07169019
Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study
Led by Alexandria University · Updated on 2025-09-11
24
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
Sponsors
A
Alexandria University
Lead Sponsor
C
Cairo University
Collaborating Sponsor
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Medical Research Institute, Alexandria University
Alexandria, Egypt, 21561
Actively Recruiting
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Research Team
A
Aliaa G. Aboulela, PhD
E
Eman M. Eleryan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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