[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577179":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Azienda Socio Sanitaria della Brianza","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"modified Mediterranean diet (DMM)","EXPERIMENTAL","It consists of a food plan in favor of bacterial biodiversity which focuses above all on foods containing high quality prebiotic fibres, instead reducing the total quantity of fibers compared to the indications provided by the Reference Intake Levels of Nutrients and Energy (LARN) for the Italian population, in consideration of the gastrointestinal side effects of chemotherapy.",[13,14],"Other: Nutrition","Other: Biological samples collection",{"label":16,"type":6,"description":17,"interventionNames":18},"standard western diet (DSO)","The Western Diet or standard diet represents the diet most commonly used by the population in many developed countries; it reflects participants' daily eating habits, ensuring that the control group accurately represents typical eating behavior.",[14],[20,26],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Nutrition","The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.",[9],[25],"Specific diet",{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Biological samples collection","Additional biological samples will also be collected.",[9,16],[31],"Microbiota analyses",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Salvatore Artale, MD","CONTACT","+390396657115","salvatore.artale@asst-brianza.it",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"U.O. di Oncologia di Vimercate, ASST-Brianza","RECRUITING","Vimercate","MB","20871","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],9.36801,45.61545,{"lat":52,"lon":51},[55],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"type":57,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[59],{"name":60,"class":6},"University of Milano Bicocca","100577179","study-on-the-impact-of-a-modified-mediterranean-diet-in-patients-with-colorectal-cancer-undergoing-active-medical-oncology-treatment-100577179",false,"NCT06794931","Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment","Randomized Pilot Study on the Impact of a Modified Mediterranean Diet (DMM) on the Intestinal Microbiota and Clinical Outcome in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment","MIC-1","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group performance status (ECOG): 0 or 1;\n* Age ≥ 18;\n* Diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to RECIST 1:1 criteria;\n* 1st line chemotherapy treatment +\u002F- biological agent (anti-EGFR, anti-VEGF);\n* MUST score 0\u002F1;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Previous oncological medical therapies;\n* Indication for parenteral and\u002For enteral nutrition;\n* MUST score \\> 2.","ALL","18 Years","80 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"NA","The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +\u002F- biological agent, comparing the microbiota with that of patients following a Western or standard diet.\n\nSpecifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the Modified Mediterranean Diet.\n\nThe study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.",[80],"Undefined",[82,83,84],"Colorectal Cancer Metastatic","modified Mediterranean diet","Intestinal microbiota","2025-01-24",{"date":87,"type":88},"2025-01-27","ACTUAL",{"date":90,"type":88},"2024-07-24",{"date":92,"type":74},"2028-07-23",{"name":5,"class":6},1]