[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504796":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":53,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Instituto Nacional de Cancerologia de Mexico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention diet","EXPERIMENTAL","Astringent diet supplemented with one sachet containing 10 grams of glutamine plus 100 million Colony Forming Units (CFU) of Lactobacillus reueri every 12 hours, from baseline treatment up to 6 weeks or death.",[13],"Combination Product: Glutamine plus L. reuteri",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard diet","NO_INTERVENTION","Astringent diet from baseline treatment up to 6 weeks or death.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Glutamine plus L. reuteri","Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death",[9],[26],"Glutapak-R",[28],{"name":29,"affiliation":30,"role":31},"Oscar G Arrieta Rodriguez, M.D., M.Sc.","Instituto Nacional de Cancerología de México","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","556280400","711101","ogar@unam.mx",[39],{"facility":5,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Mexico City","14080","Mexico","MX",{"type":46,"coordinates":47},"Point",[48,49],-99.12766,19.42847,{"lat":49,"lon":48},[52],{"name":29,"role":34,"phone":18,"phoneExt":18,"email":18},{"type":31,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Oscar Gerardo Arrieta Rodríguez","Head of the Thoracic Oncology Unit and Personalized Medicine Laboratory","100504796","phase-3-glutamine-plus-l-reuteri-prevents-tki-therapy-diarrhea-in-patients-with-nsclc-100504796",false,"NCT05852990","Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC","Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Both sexes\n* ≥ 18 years old\n* Pathologically confirmed diagnosis of NSCLC\n* Stage IIIB - IV by the American Joint Committee of Cancer Version 8.\n* Candidates to receive EGFR-TKI treatment (1st \\& 2nd generation TKI)\n* ECOG score ≤ 2\n* Life expectancy \\> eight weeks\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Patients who cannot attend the first protocol appointment.\n* Treatment with other anti-cancer therapy\n* Participating in other clinical trials in the former four weeks\n* Any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results.\n* Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.\n* Active HIV infection.\n* Breastfeeding.","ALL","18 Years","80 Years",{"count":67,"type":68},28,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy.\n\nThe main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy?\n\nPatients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.",[74],"Non-Small Cell Lung Cancer With EGFR Mutation",[76,77,78,79,80],"Non-Small Cell Lung Cancer","EGFR mutation","Glutamine","Lactobacillus reuteri","standard-care diet","2026-04-06",{"date":83,"type":84},"2026-04-09","ACTUAL",{"date":86,"type":84},"2022-03-01",{"date":88,"type":68},"2027-12-12",{"name":5,"class":6},1]