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

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.

Conditions

• Bacterial Colonization
• Multidrug Resistant Organisms
• Critical Illness
• Gut Microbiota Dysbiosis

Interventions

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy

  lead OTHER

Principal Investigators

• Constantin Bodolea · "Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2027-10-31

Completion

2027-12-31

Countries

• Romania

Study Locations