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

NCT07719673 | Not Yet Recruiting

• 1 other identifier: DEP227/25.06.2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

enteral nutrition; bacterial colonization; multidrug resistant organisms; gut microbiota; critical care

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7

  Proportion of participants who acquire new colonization with multidrug-resistant bacteria (MDRB) during ICU hospitalization, assessed between study days 5 and 7. New colonization will be defined as detection of MDRB not present at baseline (day 0) based on microbiological surveillance samples.

  ICU days 5-7 after admission

Secondary Outcomes (7)

• Change in Gut Microbiota Diversity and Composition

  From ICU admission (Day 1) to ICU days 5-7

• Proportion of Participants With MDRO Colonization at Day 14 and 28

  Day 14 and 28 after ICU admission

• Incidence of Nosocomial Infections

  From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first

• Duration of Mechanical Ventilation and Ventilator-Free Days

  Day 28 after ICU admission

• Duration of ICU and Hospital Stay

  ICU stay: From ICU admission through ICU discharge, an average of 28 days; Hospital stay: From hospital admission through hospital discharge, an average of 90 days.

Study Arms (2)

Fiber-Enriched Enteral Nutrition

EXPERIMENTAL

Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol.

Dietary Supplement: Fibre-Enriched Enteral Nutrition

Standard Enteral Nutrition Without Fiber

ACTIVE COMPARATOR

Participants will receive an enteral nutrition formula without added dietary fiber according to the study protocol.

Dietary Supplement: Standard Enteral Nutrition

Interventions

Fibre-Enriched Enteral Nutrition DIETARY_SUPPLEMENT

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.

Also known as: enteral feeding, tube feeding

Fiber-Enriched Enteral Nutrition

Standard Enteral Nutrition DIETARY_SUPPLEMENT

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.

Also known as: enteral feeding, tube feeding

Standard Enteral Nutrition Without Fiber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Emergency Military Clinical Hospital "Dr. Constantin Papilian" Cluj-Napoca

Cluj-Napoca, Romania

Location

Related Publications (12)

• Caparros T, Lopez J, Grau T. Early enteral nutrition in critically ill patients with a high-protein diet enriched with arginine, fiber, and antioxidants compared with a standard high-protein diet. The effect on nosocomial infections and outcome. JPEN J Parenter Enteral Nutr. 2001 Nov-Dec;25(6):299-308; discussion 308-9. doi: 10.1177/0148607101025006299.

  PMID: 11688933 RESULT

• Koch JL, Lew CCH, Kork F, Koch A, Stoppe C, Heyland DK, Dresen E, Lee ZY, Hill A. The efficacy of fiber-supplemented enteral nutrition in critically ill patients: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. Crit Care. 2024 Nov 7;28(1):359. doi: 10.1186/s13054-024-05128-2.

  PMID: 39511681 RESULT

• Andersen S, Kennedy G, Banks M, Flanagan B, Henden A. Prebiotic fiber enteral supplementation after allogeneic transplantation: feasibility and impact on the microbiome. Blood Adv. 2025 Aug 26;9(16):4167-4179. doi: 10.1182/bloodadvances.2024015703.

  PMID: 40489796 RESULT

• O'Keefe SJ, Ou J, Delany JP, Curry S, Zoetendal E, Gaskins HR, Gunn S. Effect of fiber supplementation on the microbiota in critically ill patients. World J Gastrointest Pathophysiol. 2011 Dec 15;2(6):138-45. doi: 10.4291/wjgp.v2.i6.138.

  PMID: 22180847 RESULT

• Freedberg DE, Messina M, Lynch E, Tess M, Miracle E, Chong DH, Wahab R, Abrams JA, Wang HH, Munck C. Impact of Fiber-Based Enteral Nutrition on the Gut Microbiome of ICU Patients Receiving Broad-Spectrum Antibiotics: A Randomized Pilot Trial. Crit Care Explor. 2020 Jun 11;2(6):e0135. doi: 10.1097/CCE.0000000000000135. eCollection 2020 Jun.

  PMID: 32695998 RESULT

• Majid HA, Cole J, Emery PW, Whelan K. Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: a randomised controlled trial. Clin Nutr. 2014 Dec;33(6):966-72. doi: 10.1016/j.clnu.2013.11.008. Epub 2013 Nov 16.

  PMID: 24290345 RESULT

• Serbanescu MA, Wright MC, Elebasy M, Shi P, Arnold JW, Haines KL, White JR, Surana NK, Wischmeyer PE. Impact of fiber-containing enteral nutrition on microbial community dynamics in critically ill trauma patients: a pilot-randomized trial. BMC Med. 2025 Dec 29;23(1):706. doi: 10.1186/s12916-025-04511-2.

  PMID: 41462238 RESULT

• Fu Y, Moscoso DI, Porter J, Krishnareddy S, Abrams JA, Seres D, Chong DH, Freedberg DE. Relationship Between Dietary Fiber Intake and Short-Chain Fatty Acid-Producing Bacteria During Critical Illness: A Prospective Cohort Study. JPEN J Parenter Enteral Nutr. 2020 Mar;44(3):463-471. doi: 10.1002/jpen.1682. Epub 2019 Aug 6.

  PMID: 31385326 RESULT

• Kamarul Zaman M, Chin KF, Rai V, Majid HA. Fiber and prebiotic supplementation in enteral nutrition: A systematic review and meta-analysis. World J Gastroenterol. 2015 May 7;21(17):5372-81. doi: 10.3748/wjg.v21.i17.5372.

  PMID: 25954112 RESULT

• Krezalek MA, Yeh A, Alverdy JC, Morowitz M. Influence of nutrition therapy on the intestinal microbiome. Curr Opin Clin Nutr Metab Care. 2017 Mar;20(2):131-137. doi: 10.1097/MCO.0000000000000348.

  PMID: 27997410 RESULT

• Goicea AE, Leucuta DC, Bodolea C. Gut Microbiota Alterations Associated With Colonization by Multidrug-Resistant Organisms in ICU Patients: First Systematic Review and Meta-Analysis. Microbiologyopen. 2026 Jun;15(3):e70322. doi: 10.1002/mbo3.70322.

  PMID: 42324777 RESULT

• Choy A, Freedberg DE. Impact of microbiome-based interventions on gastrointestinal pathogen colonization in the intensive care unit. Ther Adv Gastroenterol. 2020 Jul 17;13:1756284820939447. doi: 10.1177/1756284820939447. eCollection 2020.

  PMID: 32733601 RESULT

MeSH Terms

Conditions

Critical Illness

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Constantin Bodolea

  "Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca

  STUDY CHAIR

Central Study Contacts

Daniel Corneliu Leucuța

CONTACT

+40-597256 int 2501; dleucuta@umfcluj.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Intensive Care Physician

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)