[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511214":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":75,"collaborators":27,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":27,"maxAge":27,"enrollmentInfo":89,"targetDuration":27,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":104,"whyStopped":27,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Mansoura University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lactoferrin","EXPERIMENTAL","Lactoferrin 100 mg sachets with a dose of 200 mg (2 sachets) orally twice daily (400 mg per day) In addition to standard of care",[13],"Drug: Lactoferrin",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard","ACTIVE_COMPARATOR","Subgroup B1 will receive standard antioxidant drug (Acetyl cysteine 600 mg \u002F 12 hr) orally to be compared with lactoferrin A1 subgroup.\n\n* Subgroup B2 will receive standard anti-inflammatory, and immunomodulatory drug (dexamethasone I.V 8 mg \u002F day) to be compared with lactoferrin A2 subgroup.\n* Subgroup B3 will receive standard antibacterial drugs to be compared with lactoferrin A3 subgroup.",[19,20,21],"Drug: Antioxidant therapies","Drug: Dexamethasone","Drug: Antibacterial therapies",[23,28,32,36],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","antioxidant, immunomodulatory, anti-inflammatory, antimicrobial effect",[9],null,{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Antioxidant therapies","Acetyl cysteine 600 mg \u002F 12 hr",[15],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Dexamethasone","dexamethasone I.V 8 mg \u002F day",[15],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Antibacterial therapies","Antibacterial drugs in their approved doses",[15],[41],{"name":42,"affiliation":5,"role":43},"Ahmed H Hassan, Pharmacist","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","+201554658010","ahmedony26@gmail.com",{"name":42,"role":46,"phone":50,"phoneExt":27,"email":51},"+201155848245","ahmedony26@outlook.com",[53],{"facility":54,"status":27,"city":55,"state":56,"zip":27,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Mansoura University hospital","Al Mansurah","El-dakhlia","Egypt","EG",{"type":60,"coordinates":61},"Point",[62,63],31.38069,31.03637,{"lat":63,"lon":62},[66,68,69,70,73],{"name":67,"role":46,"phone":47,"phoneExt":27,"email":48},"Ahmed H Hassan, pharmacist",{"name":67,"role":46,"phone":50,"phoneExt":27,"email":51},{"name":42,"role":43,"phone":27,"phoneExt":27,"email":27},{"name":71,"role":72,"phone":27,"phoneExt":27,"email":27},"Sahar K Hegazy, Professor","SUB_INVESTIGATOR",{"name":74,"role":72,"phone":27,"phoneExt":27,"email":27},"Medhat M Messeha, Professor",{"type":43,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":78,"oldNameTitle":27,"oldOrganization":27},"Ahmed H Hassan, PharmD","Principal Investigator","King Salman International university","100511214","phase-4-lactoferrin-use-in-icu-patients-100511214",false,"NCT05936528","Lactoferrin Use in ICU Patients","The Effect of Lactoferrin in Improving Clinical Outcomes in ICU Patients","RCT","Inclusion Criteria:\n\n* The inclusion criteria for patients to participate in this research include adult (age ≥ 18 years) patients admitted to ICU for any reason or disease.\n\nExclusion Criteria:\n\n* inability to give informed consent by patients or their relative,\n* history of hypersensitivity to milk products,\n* history of lactoferrin use in the past 6 months,\n* patients with lactose intolerance,\n* patients with no enteral access to administer LF either orally or by Ryle tube,\n* patients who are expected to die within 48 hours, and\n* patients with poor oral absorption as in case of shock and resected bowel.",true,"ALL",{"count":90,"type":91},660,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","Introduction:\n\nLactoferrin has several uses due to its effects. It has anti-inflammatory, antioxidant, immunomodulatory, antibacterial, antifungal, and antiviral effects. Its safety is proven by food and drug administration.\n\nAims:\n\nThe objective is to study the effect of lactoferrin on improving clinical outcomes in ICU patients, and also to evaluate its safety.\n\nPatients and populations:\n\nA sample of 660 patients (330 patients in both groups A, and B) who will be admitted to ICU departments in Mansoura university hospital will be used to represent the population in ICU.\n\nMethods:\n\nA sample of 660 participants was randomized 1:1 into two groups (group A (330 patients), and group B (330 patients)).\n\nThis study is a single blind, randomized controlled clinical trial. Randomization was performed by independent clinical pharmacists working in hospital ICU departments.",[97],"Critical Illness",[99,100,9,101,102,103],"Clinical outcomes","ICU patients","Antioxidant therapy","Anti-inflammatory therapy","Antimicrobial therapy","NOT_YET_RECRUITING","2025-07-23",{"date":107,"type":108},"2025-07-28","ACTUAL",{"date":110,"type":91},"2025-12-29",{"date":112,"type":91},"2027-12-29",{"name":5,"class":6},1]