Bacterial Colonization, Critical Illness, Gut Microbiota Dysbiosis, Multidrug Resistant Organisms
Conditions
Keywords
enteral nutrition, bacterial colonization, multidrug resistant organisms, gut microbiota, critical care
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.
Detailed description
Critically ill patients frequently experience alterations of the intestinal microbiota due to factors such as severe illness, antibiotic exposure, and the ICU environment. These changes may contribute to loss of colonization resistance and increased susceptibility to acquisition of multidrug-resistant bacteria, which are associated with increased morbidity and mortality in critically ill populations. Enteral nutrition is commonly used in ICU patients who are unable to meet their nutritional requirements orally. Beyond its role in providing calories and nutrients, enteral nutrition may influence intestinal barrier function and microbiota composition. Fiber-containing enteral formulas include nondigestible carbohydrates that may act as substrates for microbial fermentation and may promote the growth of beneficial bacterial populations and the production of short-chain fatty acids. Previous studies have suggested that fiber supplementation during enteral nutrition may influence gut microbiota composition and clinical outcomes; however, results remain inconsistent, particularly in critically ill patients receiving broad-spectrum antibiotics. The potential effect of fiber-enriched enteral nutrition on acquisition of multidrug-resistant bacterial colonization has not been adequately investigated. This clinical trial aims to evaluate whether modulation of the intestinal microbiota through fiber-enriched enteral nutrition may influence colonization resistance in critically ill patients. The study will provide preliminary data regarding microbiota changes associated with enteral nutrition strategies and their potential relationship with multidrug-resistant bacterial colonization. These findings may support the design of future larger clinical trials evaluating nutritional interventions as a strategy to preserve microbiome function and reduce ICU-associated complications.
Interventions
DIETARY_SUPPLEMENTFibre-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_SUPPLEMENTStandard 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
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7 | ICU days 5-7 after admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbiota Diversity and Composition | From ICU admission (Day 1) to ICU days 5-7 | Changes in intestinal microbiota diversity and composition between baseline and follow-up samples, assessed by microbiome analysis of stool samples. |
| Proportion of Participants With MDRO Colonization at Day 14 and 28 | Day 14 and 28 after ICU admission | Proportion of participants with MDRB colonization detected on surveillance microbiological samples among participants who continue receiving enteral nutrition. |
| Incidence of Nosocomial Infections | From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first | Incidence and type of nosocomial infections occurring during ICU hospitalization. |
| Duration of Mechanical Ventilation and Ventilator-Free Days | Day 28 after ICU admission | Duration of invasive mechanical ventilation and number of ventilator-free days during the first 28 days 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. | Duration of intensive care unit stay and total hospital length of stay. |
| 28-Day Mortality and In-Hospital Mortality | 28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days. | All-cause mortality occurring within 28 days after ICU admission and during the index hospital admission. |
| Correlation Between Immunological and Inflammatory Profile Changes and MDRB Colonization or Microbiota Changes | From ICU admission (Day 1) to Day 28 after ICU admission | Correlation between longitudinal changes in inflammatory and immunological markes, and changes in MDRB colonization status and intestinal microbiota composition. Biomarkers will include routine laboratory parameters (e.g., leukocyte differential count, C-reactive protein, fibrinogen, erythrocyte sedimentation rate, ferritin) and immunological markers (e.g., immunoglobulins IgA, IgG, IgM, IgE, complement C3 and C4), and will be reported using their respective standard clinical laboratory units. MDRB colonization will be assessed by microbiological culture and reported for ESBL-producing organisms, CRE, MRSA, VRE. Intestinal microbiota composition will be characterized by next-generation sequencing and reported using taxonomic relative abundance and diversity indices. |
Countries
Romania
Contacts
CONTACTDaniel Corneliu Leucuța
STUDY_CHAIRConstantin Bodolea
"Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca
Outcome results
None listed