[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-profiles\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-profiles":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100659549","gut-microbiota-structure-functional-and-metabolic-profiles-and-composite-biomarkers-in-icu-adults-with-refractory-enteral-feeding-intolerance-100659549",false,"NCT07864844","Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance","Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance: A Prospective Observational Longitudinal Cohort Study","Inclusion Criteria:\n\n* Age ≥18 years.\n* Receiving care in the ICU at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.\n* Meeting the protocol-defined criteria for refractory enteral feeding intolerance (rEFI): inability to achieve an enteral energy intake of 20 kcal\u002Fkg\u002Fday despite 72 consecutive hours of feeding strategy adjustments and standard measures, including prokinetic medications.\n* A spontaneously passed stool sample can be obtained, or a rectal swab can be safely collected, within the permitted baseline sampling window.\n* Written informed consent provided by the participant or their legally authorized representative. Participants who regain decision-making capacity will be informed again and asked to consent to continued participation.\n\nExclusion Criteria:\n\n* Pregnancy or reasonable grounds for the investigator to suspect pregnancy. Active inflammatory bowel disease, major gastrointestinal surgery, or any other condition within the past 3 months that significantly alters intestinal anatomy and affects interpretation of the study findings.\n* Receipt of fecal microbiota transplantation before ICU admission.\n* Active gastrointestinal bleeding, severe coagulopathy, anorectal surgery or lesions, or other conditions that make rectal swab collection unsafe, together with an inability to obtain a spontaneously passed stool sample within the specified sampling window.\n* Expected death within 24 hours, with informed consent and baseline procedures unable to be completed without interfering with emergency care.\n* Refusal to participate by the participant or their legally authorized representative, or determination by the investigator that enrollment is inappropriate because of concerns regarding safety, adherence to study procedures, or data validity.","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","OBSERVATIONAL","Some adults in the intensive care unit (ICU) cannot receive enough nutrition through a feeding tube because of persistent digestive problems, even after standard measures to improve feeding. This condition is called refractory enteral feeding intolerance. The community of microorganisms living in the gut, known as the gut microbiota, and the substances produced by these microorganisms and the body may be associated with feeding tolerance and recovery.\n\nThis prospective observational study will enroll approximately 180 adults with refractory enteral feeding intolerance at a single hospital. It aims to describe changes in their gut microbiota and metabolic profiles over time and identify combinations of microbial markers associated with improved feeding tolerance and adequate nutritional intake.\n\nStool samples or rectal swabs will be collected at enrollment, on days 3-5 and day 7, and, when feasible, near the end of the ICU stay. The samples will be used to examine the types of microorganisms present. Selected samples will also be analyzed for metabolic substances. Clinical information about nutrition, digestive symptoms, medications, illness severity, and treatments will be collected. Participants will be followed for up to 90 days to assess survival and unplanned hospital readmissions.\n\nThe study will examine whether microbial and metabolic patterns provide additional information about feeding improvement by day 7 beyond routine clinical assessments. Where suitable public datasets are available, findings will also be evaluated in other patient groups.\n\nParticipants will continue to receive usual medical care. The study does not assign treatments or change feeding decisions. Its findings may help guide future research on feeding intolerance, but participants are not expected to receive a direct medical benefit from taking part.",[24,25,26],"Refractory Enteral Feeding Intolerance","Gut Microbiota","Metabolic Profiles","NOT_YET_RECRUITING","2026-10-01",{"date":30,"type":31},"2026-10-08","ACTUAL",{"date":33,"type":20},"2026-10-15",{"date":35,"type":20},"2027-12-30",{"name":37,"class":38},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER"]