[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575423":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":30,"responsibleParty":41,"collaborators":30,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":30,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":30,"enrollmentInfo":52,"targetDuration":30,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":30,"overallStatus":62,"whyStopped":30,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":30},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 0: Placebo","PLACEBO_COMPARATOR","The placebo will also be manufactured and provided by the commercial provider.",[13],"Other: Placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1: Placebo","Placebo capsules of the same size and shape to be taken daily for 12 weeks. The placebo will also be manufactured and provided by the commercial provider.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Phase 1: Treatment","ACTIVE_COMPARATOR","50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks",[23],"Biological: Lactobacillus and Bifidobacterium",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Lactobacillus and Bifidobacterium","Each lot of Lactobacillus and Bifidobacterium and placebo capsules to be used in this study will undergo bioburden testing (tested as per USP \\\u003C61\\>) to ensure that each lot has:\n\n* Not more than 2000 colony forming unit (CFU) of contaminating (other than the seven strains of bacteria used in the Lactobacillus and Bifidobacterium capsules) aerobic bacteria per gram or dose (whichever is greater);\n* Not more than 200 CFU of yeasts and molds per gram or dose (whichever is greater); and\n* No bile-tolerant Gram-negative bacteria, Escherichia coli, Salmonella species (in 10 gm), Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium species per gram or dose (whichever is greater; tested as per USP\\\u003C62\\>).",[19],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo","Placebo capsule manufactured in same facility as experimental capsule.",[9,15],[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Ajay Prakash, MD, PhD","CONTACT","612-624-9452","praka086@umn.edu",{"type":42,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100575423","probiotic-supplementation-during-cytotoxic-chemotherapy-for-solid-tumor-malignancies-100575423",false,"NCT06772090","Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies","A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies","Inclusion Criteria:\n\n* Adults ≥18 years old\n* Diagnosis of stage III colon cancer\n* Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.\n\nExclusion Criteria:\n\n* Allergy or sensitivity to probiotic supplementation\n* Diagnosis\u002Fhistory of:\n\nNon-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures\n\n* Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences\n* Current participation in another interventional study of medication(s)\n* Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet\n* BMI ≥40 kg\u002Fm2 or ≤17 kg\u002Fm2\n* Unexpected change in weight of ˃4.5 kg within the past 6 months","ALL","18 Years",{"count":53,"type":54},40,"ESTIMATED","INTERVENTIONAL",[57],"NA","This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.",[60,61],"Solid Tumor, Adult","Cytotoxicity","NOT_YET_RECRUITING","2026-02-02",{"date":65,"type":66},"2026-02-03","ACTUAL",{"date":68,"type":54},"2026-12-25",{"date":70,"type":54},"2028-12-31",{"name":5,"class":6}]