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

Starting soon · Not applicable

Conditions studied: Bacterial Colonization, Multidrug Resistant Organisms, Critical Illness, Gut Microbiota Dysbiosis

In brief

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.

Key facts

Study ID

NCT07719673

Run by

Iuliu Hatieganu University of Medicine and Pharmacy

People needed

60

Starts

2026-10-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with medical (non-surgical) conditions admitted to the ICU.
• ICU admission within the previous 48 hours at the study site.
• Initiation of enteral nutrition within the first 48 hours after ICU admission.
• Written informed consent obtained for participation in the study.

You may not qualify if…

• Surgical ICU patients.
• Patients in whom enteral nutrition was not initiated within the first 48 hours after - ICU admission.
• Patients with galactosemia.
• Patients with major contraindications to enteral nutrition, including: intestinal obstruction, intestinal ischemia, intestinal perforation, severe hemodynamic instability, patients who refuse participation in the study.

Where it is running

• Emergency Military Clinical Hospital "Dr. Constantin Papilian" Cluj-Napoca — Cluj-Napoca, Romania

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.