[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641573":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":42,"collaborators":44,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":25,"enrollmentInfo":57,"targetDuration":25,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":25},{"fullName":5,"class":6},"Fondazione ANT Franco Pannuti ETS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic Mixture","EXPERIMENTAL","Participants will receive an oral probiotic mixture twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. Assessments will be performed at baseline, 6 weeks, and 12 weeks during home visits.",[13],"Dietary Supplement: Probiotic Mixture",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive a placebo orally twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. The placebo will be provided in sachets identical in appearance, taste, and administration schedule to the probiotic mixture. Assessments will be performed at baseline, 6 weeks, and 12 weeks during home visits.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Participants assigned to this intervention will receive an oral probiotic mixture twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. The probiotic mixture will be administered in sachets and taken orally twice daily for 12 weeks.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants assigned to this intervention will receive a placebo orally twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. The placebo will be provided in sachets identical in appearance, taste, and administration schedule to the probiotic mixture and will contain no active bacteria.",[15],[30],{"name":31,"affiliation":5,"role":32},"Enrico Ruggeri, Medicine","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Rita Ostan, Biological Sciences","CONTACT","+393487900191","rita.ostan@ant.it",{"name":31,"role":36,"phone":40,"phoneExt":25,"email":41},"+393483102998","enrico.ruggeri@ant.it",{"type":43,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[45],{"name":46,"class":6},"University of Bologna","100641573","cachexia-and-gut-microbiota-in-patients-with-breast-cancer-receiving-home-care-100641573",false,"NCT07653698","Cachexia and Gut Microbiota in Patients With Breast Cancer Receiving Home Care","Evaluation of Cancer Cachexia and Analysis of Gut Microbiota in Patients With Breast Cancer Receiving Home Care","GM_ANT","Inclusion Criteria\n\n* Female patients with Breast Cancer (BC)\n* Age ≥ 18 years\n* Able to understand the study objectives and provide written informed consent\n* Able to speak and understand Italian\n\nExclusion Criteria\n\n* Antibiotic treatment within the previous 2 weeks\n* Use of probiotic supplements within the previous month\n* Artificial nutrition (enteral or parenteral)\n* Severe dysphagia, intestinal obstruction, or impaired gastrointestinal function\n* Diagnosis of dementia or cognitive impairment preventing understanding of the study information and\u002For provision of informed consent\n* Severe organ failure\n* Refusal to participate For the interventional phase: refractory cachexia and\u002For life expectancy of less than 6 weeks","FEMALE","18 Years",{"count":58,"type":59},140,"ESTIMATED","INTERVENTIONAL",[62],"NA","This study aims to evaluate the possible association between cancer cachexia and Gut Microbiota (GM) in patients with Breast Cancer (BC) cared at home.\n\nCancer cachexia is a multifactorial condition causing weight loss, muscle loss, and reduced physical strength in people with cancer. Moreover, the study will also analyze whether different stages of cachexia are linked to changes in the GM.\n\nThe study will also explore whether a supplementation with a probiotic mixture for twelve weeks is associated with changes in the GM and participants' nutritional and clinical condition.\n\nThe effect of the probiotic mixture (experimental group) will be compared with a placebo (control group) to evaluate whether changes in the GM and in cachexia-related measures differ between the two groups.\n\nParticipants will:\n\n* Provide blood, stool, and urine samples to study the GM and biological markers.\n* Answer questionnaires about symptoms and quality of life.\n* Undergo assessments of nutritional status and body composition.\n\nParticipants eligible for the intervention will take either a probiotic mixture or a placebo for twelve weeks.\n\nAll study procedures will take place during home visits as part of the participants' regular home care program.",[65,66],"Breast Cancer","Cancer Cachexia",[65,68,69,70,9,71],"Cancer cachexia","Gut Microbiota","Palliative Care","Dysbiosis","NOT_YET_RECRUITING","2026-06-16",{"date":75,"type":76},"2026-06-17","ACTUAL",{"date":78,"type":59},"2026-06-01",{"date":80,"type":59},"2028-08-31",{"name":5,"class":6}]