[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605937":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":42,"locations":52,"responsibleParty":70,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Alexandria University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotics and methotrexate group","EXPERIMENTAL","Patients will receive weekly oral methotrexate 15-25 mg\u002Fweek, along with an oral daily dose of probiotics.",[13],"Drug: Probiotics and methotrexate",{"label":15,"type":16,"description":17,"interventionNames":18},"Methotrexate group","ACTIVE_COMPARATOR","Patients will receive weekly oral methotrexate 15-25 mg\u002Fweek.",[19],"Drug: Methotrexate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Probiotics and methotrexate","weekly oral methotrexate 15-25 mg\u002Fweek, along with an oral daily dose of probiotics.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Methotrexate","weekly oral methotrexate 15-25 mg\u002Fweek",[15],[32,36,39],{"name":33,"affiliation":34,"role":35},"Ezzeldin A. Saleh, PhD","Medical Research Institute, Alexandria University","STUDY_CHAIR",{"name":37,"affiliation":34,"role":38},"Gamaleldin A. Elsawaf, PhD","STUDY_DIRECTOR",{"name":40,"affiliation":34,"role":41},"Mohamed A. Alqasem, MSc","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Aliaa G. Aboulela, PhD","CONTACT","+201002104138","aliaagamaleldin@alexu.edu.eg",{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},"Eman M. Eleryan, MD","+201001538935","eman.elaryan@alexmed.edu.eg",[53],{"facility":34,"status":54,"city":55,"state":26,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Alexandria","21561","Egypt","EG",{"type":60,"coordinates":61},"Point",[62,63],29.91582,31.20176,{"lat":63,"lon":62},[66,67,69],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},{"name":68,"role":45,"phone":50,"phoneExt":26,"email":51},"Eman M. Eleryan., MD.",{"name":40,"role":41,"phone":26,"phoneExt":26,"email":26},{"type":41,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Aliaa Gamaleldin Aboulela","Associate Professor of Microbiology",[74],{"name":75,"class":6},"Cairo University","100605937","early-phase-1-microbiome-and-clinical-response-to-probiotics-and-methotrexate-in-early-psoriasis-a-pilot-study-100605937",false,"NCT07169019","Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study","Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study","Inclusion Criteria:\n\n* Newly diagnosed patients with chronic plaque psoriasis.\n\nExclusion Criteria:\n\n* • Psoriatic patients who used systemic treatments at least 3 months before the study, with the exception of acetritin use, in the last 3 years.\n\n  * Patients who have skin infection or other skin or autoimmune diseases such as SLE, Lichen planus, Dermatomyositis and Vitiligo, by history and examination.\n  * Pregnant or Lactating mothers.\n  * Patients with any contraindication to methotrexate treatment.\n  * 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.\n  * Patients with low intellectual capacity, uneducated patients, or patients unable or unwilling to provide daily feedback about their compliance to the provided probiotics treatment.","ALL","18 Years",{"count":86,"type":87},24,"ESTIMATED","INTERVENTIONAL",[90],"EARLY_PHASE1","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:\n\nDo 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.\n\nParticipants will:\n\nTake a daily dose of probiotics with a weekly dose of methotrexate or only a weekly dose of methotrexate for 4 months.\n\nGive daily feedback to the researchers about their probiotic intake and their dietary intake.\n\nVisit the clinic after 1 and 2 weeks of beginning treatment and then once every 4 weeks for checkups and tests.",[93],"Psoriasis (PsO)",[95,96,97,98],"Psoriasis","gut microbiome","methotrexate","probiotics","2025-09-05",{"date":101,"type":102},"2025-09-11","ACTUAL",{"date":104,"type":102},"2025-08-01",{"date":106,"type":87},"2026-12-30",{"name":5,"class":6},1]