Clinical Trial

Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients

Study acronym: MICRON
Not Yet Recruiting
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Summary
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. The main questions it aims to answer are: * Does fiber-enriched enteral nutrition reduce the acquisition of colonization with multidrug-resistant bacteria during intensive care unit (ICU) hospitalization? * Does fiber-enriched enteral nutrition modify the composition and diversity of the intestinal microbiota? * Are there differences in clinical outcomes, including adverse events, between patients receiving fiber-enriched and non-fiber enteral nutrition? Researchers 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. Participants will: * Receive enteral nutrition through a feeding tube according to their clinical needs. * Receive either a fiber-enriched enteral nutrition formula or a standard enteral nutrition formula. * Have stool samples collected during ICU hospitalization for analysis of intestinal microbiota and detection of multidrug-resistant bacteria. * Be monitored for clinical outcomes, infections, antibiotic exposure, and adverse events during their ICU stay and follow-up period.
Trial Details
NCT Number NCT07719673
Lead Sponsor Iuliu Hatieganu University of Medicine and Pharmacy
Conditions Bacterial Colonization, Multidrug Resistant Organisms, Critical Illness, Gut Microbiota Dysbiosis
Enrollment 60 participants
Start Date 2026-10
Primary Completion 2027-10 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-22