[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549008":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":74,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":26,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Necmettin Erbakan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The intervention group will receive an oral dosage of 4 x 10\\^9 cfu\u002Fg\u002Fday Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg\u002Fkg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks.\n\nA probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.",[13],"Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04",{"label":15,"type":16,"description":17,"interventionNames":18},"Plasebo group","PLACEBO_COMPARATOR","The plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg\u002Fkg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks.\n\nIn addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g\u002Fday maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.",[19],"Other: Plasebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Bifidobacterium animalis subsp. lactis Bl-04","4 x 10\\^9 cfu\u002Fg\u002Fday Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Plasebo","1 g\u002Fday maltodextrin for 12 weeks",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Mehmet Artaç, MD","CONTACT","+90332236000","6434","martac@erbakan.edu.tr",[39],{"facility":5,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":26,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Konya","42090","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],32.48464,37.87135,{"lat":48,"lon":47},[51,53,55,58,60,62,64,66,68,70,72],{"name":33,"role":34,"phone":52,"phoneExt":36,"email":37},"+903322236000",{"name":33,"role":54,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":57,"phone":26,"phoneExt":26,"email":26},"Hasibe Artaç, MD","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":26,"phoneExt":26,"email":26},"Murat Araz, MD",{"name":61,"role":57,"phone":26,"phoneExt":26,"email":26},"Melek Karakurt Eryılmaz, MD",{"name":63,"role":57,"phone":26,"phoneExt":26,"email":26},"Selin Uğraklı, MD",{"name":65,"role":57,"phone":26,"phoneExt":26,"email":26},"Yunus Emre Tunçil, PhD",{"name":67,"role":57,"phone":26,"phoneExt":26,"email":26},"Mehmet Zahid Koçak, MD",{"name":69,"role":57,"phone":26,"phoneExt":26,"email":26},"Muzaffer Uğraklı, MD",{"name":71,"role":57,"phone":26,"phoneExt":26,"email":26},"Ayça Ceylan, PhD",{"name":73,"role":57,"phone":26,"phoneExt":26,"email":26},"Şenay Burçin Alkan, PhD",{"type":54,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Mehmet Artac","Prof.Dr.",[78],{"name":79,"class":80},"Health Institutes of Turkey","OTHER_GOV","100549008","the-impact-of-probiotic-on-survival-and-treatment-response-in-metastatic-non-small-cell-lung-cancer-patients-100549008",false,"NCT06428422","The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients","The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)","Inclusion Criteria:\n\n* Volunteering to participate in the study.\n* Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).\n* Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV).\n* Male or female patients aged \\>18 years.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.\n* Laboratory findings must confirm adequate bone marrow function, indicated by:\n\nWhite Blood Cell (WBC) count \\> 2,000\u002Fmm³, Neutrophil count \\> 1,500\u002Fmm³,Platelet count \\> 100,000\u002Fmm³\n\nExclusion Criteria:\n\n* Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4.\n* Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements.\n* Antibiotic utilization within the past month\n* Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.\n* A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.\n* Presence of uncontrolled adrenal insufficiency.\n* Pregnancy or breastfeeding.\n* Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.\n* Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.","ALL","19 Years","90 Years",{"count":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96],"NA","The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.",[99],"Metastatic Non-small Cell Lung Cancer",[101,102,103,104,105],"immunotherapy","lung cancer","probiotics","Bifidobacterium animalis","microbiota","2024-08-14",{"date":108,"type":109},"2024-08-16","ACTUAL",{"date":111,"type":109},"2024-08-12",{"date":113,"type":93},"2026-12-20",{"name":5,"class":6},1]