[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641649":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":18,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","ACTIVE_COMPARATOR","30 patients will receive palmitoylethanolamide (PEA® hard gelatin capsules) 600 mg\u002Fday in addition to their standard therapy according to the European Crohn and Colitis Organization (ECCO) guidelines for 3 months. Standard therapy consists of: 5-Aminosalicylates, corticosteroids and azathioprine.",[13],"Dietary Supplement: Palmitoylethanolamide (PEA)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","30 patients will receive their standard therapy according to the ECCO guidelines for 3 months. Standard therapy consists of: 5-Aminosalicylates, corticosteroids and azathioprine.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Palmitoylethanolamide (PEA)","Palmitoylethanolamide (PEA) is an endocannabinoid-like bioactive lipid mediator which belongs to the family of N-acylethanolamine (NAE) fatty acid amides. It exerts anti-inflammatory, antioxidant, antimicrobial, analgesic, immunomodulatory and neuroprotective actions through acting at different sites like: PPAR-α, G-protein coupled receptor 55 (GPR55), cannabinoid receptors 1 and 2 (CB1 and CB2) and transient receptor potential vanilloid receptor 1 (TRPVR1) channels. PEA is a commercially available supplement mainly used to alleviate chronic neuropathic pain and persistent musculoskeletal pain. PEA has proven to be safe and tolerable across multiple studies with very rare cases reporting mild side effects like: intermittent headache, nausea, constipation, urticaria and fatigue. It will be given in this study at a dose of 600 mg\u002Fday",[9],[26,30,33],{"name":27,"affiliation":28,"role":29},"Sarah Farid Mohammed, Associate professor","Faculty of Pharmacy, Ain-Shams University","STUDY_DIRECTOR",{"name":31,"affiliation":32,"role":29},"Hagar Ahmed Elessawy, Associate professor","Faculty of Medicine, Ain-Shams University",{"name":34,"affiliation":28,"role":29},"Nagwa Ali Sabri, Professor",[36],{"name":37,"role":38,"phone":39,"phoneExt":18,"email":40},"Ahmed Emad Sayed, Teaching Assistant","CONTACT","+201007546334","ahmed.emad18@pharma.asu.edu.eg",[42],{"facility":43,"status":18,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital","Cairo","El-Abbasia","11252","Egypt","EG",{"type":50,"coordinates":51},"Point",[52,53],31.24967,30.06263,{"lat":53,"lon":52},[56,57],{"name":37,"role":38,"phone":39,"phoneExt":18,"email":40},{"name":31,"role":58,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ahmed Emad","Teaching assistant in Clinical Pharmacy Department","100641649","palmitoylethanolamide-in-ulcerative-colitis-100641649",false,"NCT07609810","Palmitoylethanolamide in Ulcerative Colitis","The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients","Inclusion Criteria:\n\n* Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.\n* Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and \\\u003C 12 at screening, not responding to 5-aminosalicylates (5-ASA) defined as persistent rectal bleeding beyond 2 weeks or failure to achieve sustained symptom relief after 40 days of appropriate 5-ASA therapy, steroid-dependent defined as unable to reduce steroids below the equivalent of prednisolone 10 mg\u002Fday or budesonide below 3 mg\u002Fday within 3 months of starting steroids, without recurrent active disease or who have a relapse within 3 months of stopping steroids and they currently take azathioprine.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Alcohol or drug abuse.\n* Allergy or known hypersensitivity to palmitoylethanolamide.\n* Active infection (enteric or systemic).\n* Uncontrolled metabolic\u002F neurologic conditions: uncontrolled hypertension, uncontrolled diabetes, migraine disorders or other uncontrolled neurologic disease.\n* Other autoimmune diseases.\n* Severe or acute severe colitis requiring hospitalization.\n* UC patients requiring colectomy.\n* Crohn disease (CD), chronic pancreatitis, cholecystitis or other inflammatory conditions involving the gastrointestinal tract (GIT).\n* Patients with renal or liver disease.\n* Patients who have never been treated for UC.\n* Any patients on biologics.\n* Patients using NSAIDs or aspirin (due to interference with fecal calprotectin results).","ALL","18 Years","65 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.",[81],"Ulcerative Colitis (UC)",[83],"palmitoylethanolamide - endocannabinoid - disease activity","NOT_YET_RECRUITING","2026-06-12",{"date":87,"type":88},"2026-06-16","ACTUAL",{"date":90,"type":75},"2026-07-15",{"date":92,"type":75},"2029-02-15",{"name":5,"class":6},1]