An interventional study of Fibre-Enriched Enteral Nutrition and Standard Enteral Nutrition in Bacterial Colonization, Multidrug Resistant Organisms and Critical Illness, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Not yet recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Not applicable, Interventional, and Prevention
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:
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:
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 56 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol.
Dietary Supplement: Fibre-Enriched Enteral Nutrition
Participants will receive an enteral nutrition formula without added dietary fiber according to the study protocol.
Dietary Supplement: Standard 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.
Also known as: enteral feeding, tube feeding
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
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.
Time frame: ICU days 5-7 after admission
Change in Gut Microbiota Diversity and Composition
Changes in intestinal microbiota diversity and composition between baseline and follow-up samples, assessed by microbiome analysis of stool samples.
Time frame: From ICU admission (Day 1) to ICU days 5-7
Proportion of Participants With MDRO Colonization at Day 14 and 28
Proportion of participants with MDRB colonization detected on surveillance microbiological samples among participants who continue receiving enteral nutrition.
Time frame: Day 14 and 28 after ICU admission
Incidence of Nosocomial Infections
Incidence and type of nosocomial infections occurring during ICU hospitalization.
Time frame: From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
Duration of Mechanical Ventilation and Ventilator-Free Days
Duration of invasive mechanical ventilation and number of ventilator-free days during the first 28 days after ICU admission.
Time frame: Day 28 after ICU admission
Duration of ICU and Hospital Stay
Duration of intensive care unit stay and total hospital length of stay.
Time frame: 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.
28-Day Mortality and In-Hospital Mortality
All-cause mortality occurring within 28 days after ICU admission and during the index hospital admission.
Time frame: 28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
Correlation Between Immunological and Inflammatory Profile Changes and MDRB Colonization or Microbiota Changes
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.
Time frame: From ICU admission (Day 1) to Day 28 after ICU admission
Plan to share: No — Individual participant data will not be shared because the study involves a relatively small number of critically ill patients and includes detailed clinical and microbiological information that may present privacy and confidentiality risks. Data will be handled according to applicable ethical and data protection requirements.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Iuliu Hatieganu University of Medicine and Pharmacy