[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648300":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":63,"collaborators":44,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":44,"enrollmentInfo":77,"targetDuration":44,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":95,"whyStopped":44,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Iuliu Hatieganu University of Medicine and Pharmacy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fiber-Enriched Enteral Nutrition","EXPERIMENTAL","Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol.",[13],"Dietary Supplement: Fibre-Enriched Enteral Nutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Enteral Nutrition Without Fiber","ACTIVE_COMPARATOR","Participants will receive an enteral nutrition formula without added dietary fiber according to the study protocol.",[19],"Dietary Supplement: Standard Enteral Nutrition",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Fibre-Enriched Enteral Nutrition","Participants will receive enteral nutrition administered through an enteral feeding tube according to their clinical nutritional requirements. The intervention consists of an enteral nutrition formula enriched with dietary fiber, including fermentable fibers with potential prebiotic effects, intended to modulate intestinal microbiota composition and function. It will be administered according to the study protocol and clinical care requirements of critically ill patients. The intervention will be initiated during intensive care unit hospitalization and continued according to patient tolerance and clinical indications. The type and amount of enteral nutrition administered will be documented throughout the study period.",[9],[27,28],"enteral feeding","tube feeding",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Standard Enteral Nutrition","Participants will receive enteral nutrition administered through an enteral feeding tube according to their clinical nutritional requirements. The comparator intervention consists of a standard enteral nutrition formula without added fiber. It will be administered according to the study protocol and clinical care requirements of critically ill patients. The type and amount of enteral nutrition administered will be documented throughout the study period.",[15],[27,28],[35],{"name":36,"affiliation":37,"role":38},"Constantin Bodolea","\"Iuliu Hațieganu\" University of Medicine and Pharmacy Cluj-Napoca","STUDY_CHAIR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Daniel Corneliu Leucuța","CONTACT","+40-597256 int 2501",null,"dleucuta@umfcluj.ro",[47],{"facility":48,"status":44,"city":49,"state":44,"zip":44,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Emergency Military Clinical Hospital \"Dr. Constantin Papilian\" Cluj-Napoca","Cluj-Napoca","Romania","RO",{"type":53,"coordinates":54},"Point",[55,56],23.6,46.76667,{"lat":56,"lon":55},[59],{"name":60,"role":42,"phone":61,"phoneExt":44,"email":62},"Andra Elena Goicea","+40723712665","goiceaandraelena@elearn.umfcluj.ro",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Andra-Elena Goicea","Anesthesia and Intensive Care Physician","100648300","enteral-nutrition-and-colonization-resistance-through-microbiota-modulation-in-critically-ill-patients-100648300",false,"NCT07719673","Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients","Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial","MICRON","Inclusion Criteria:\n\n* Patients with medical (non-surgical) conditions admitted to the ICU.\n* ICU admission within the previous 48 hours at the study site.\n* Initiation of enteral nutrition within the first 48 hours after ICU admission.\n* Written informed consent obtained for participation in the study.\n\nExclusion Criteria:\n\n* Surgical ICU patients.\n* Patients in whom enteral nutrition was not initiated within the first 48 hours after - ICU admission.\n* Patients with galactosemia.\n* Patients with major contraindications to enteral nutrition, including: intestinal obstruction, intestinal ischemia, intestinal perforation, severe hemodynamic instability, patients who refuse participation in the study.","ALL","18 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn whether enteral nutrition enriched with fiber can influence gut microbiota and improve resistance to colonization with multidrug-resistant bacteria in critically ill patients. The study will also evaluate the safety and clinical outcomes associated with fiber-enriched enteral nutrition.\n\nThe main questions it aims to answer are:\n\n* Does fiber-enriched enteral nutrition reduce the acquisition of colonization with multidrug-resistant bacteria during intensive care unit (ICU) hospitalization?\n* Does fiber-enriched enteral nutrition modify the composition and diversity of the intestinal microbiota?\n* Are there differences in clinical outcomes, including adverse events, between patients receiving fiber-enriched and non-fiber enteral nutrition?\n\nResearchers will compare patients receiving fiber-enriched enteral nutrition with patients receiving standard enteral nutrition without added fiber to determine whether fiber supplementation influences gut microbiota and colonization resistance.\n\nParticipants will:\n\n* Receive enteral nutrition through a feeding tube according to their clinical needs.\n* Receive either a fiber-enriched enteral nutrition formula or a standard enteral nutrition formula.\n* Have stool samples collected during ICU hospitalization for analysis of intestinal microbiota and detection of multidrug-resistant bacteria.\n* Be monitored for clinical outcomes, infections, antibiotic exposure, and adverse events during their ICU stay and follow-up period.",[85,86,87,88],"Bacterial Colonization","Multidrug Resistant Organisms","Critical Illness","Gut Microbiota Dysbiosis",[90,91,92,93,94],"enteral nutrition","bacterial colonization","multidrug resistant organisms","gut microbiota","critical care","NOT_YET_RECRUITING","2026-07-20",{"date":98,"type":99},"2026-07-22","ACTUAL",{"date":101,"type":79},"2026-10",{"date":103,"type":79},"2027-12",{"name":5,"class":6},1]