Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
ConditionPsoriasis (PsO)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed patients with chronic plaque psoriasis.
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotics and methotrexate
Drugweekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics.
Methotrexate
Drugweekly oral methotrexate 15-25 mg/week
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Probiotics and methotrexate groupExperimental treatment 1 intervention
Group B: Methotrexate groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 treatment with methotrexate alone.
The composition of gut microbiota before the start of treatment and after the end of the treatment course will be determined by analysis of a stool sample from each participant by illumina Next generation sequencing and 16S Metagenomics bioinformatics analysis of data to identify microbial taxa in the samples. The clinical impact induced by treatment of newly diagnosed psoriatic patients with probiotics and methotrexate or methotrxate alone will be determined by the calculation of PASI score before and after treatment.
Time frame
One yearSponsors and contacts
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Alexandria University
Lead sponsor
Cairo University
Collaborator
Source ClinicalTrials.gov