Bacterial ColonizationMICRONNCT07719673
Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients
A study testing Fibre-Enriched Enteral Nutrition and Standard Enteral Nutrition in people with Bacterial Colonization and Multidrug Resistant Organisms, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Colonization, Multidrug Resistant Organisms, Critical Illness
- What is being tested?
- Fibre-Enriched Enteral Nutrition and Standard Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Emergency Military Clinical Hospital "Dr. Constantin Papilian" Cluj-Napoca
Cluj-Napoca
Andra Elena Goicea, +40723712665, goiceaandraelena@elearn.umfcluj.ro
About this study
Official title: Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial
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:
Read more
- 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.
Read the 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.
- Conditions
- Bacterial Colonization, Multidrug Resistant Organisms, Critical Illness, Gut Microbiota Dysbiosis
- Being tested
- Fibre-Enriched Enteral Nutrition, Standard Enteral Nutrition
- Keywords
- enteral nutrition, bacterial colonization, multidrug resistant organisms, gut microbiota, critical care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibre-Enriched Enteral NutritionDietary supplement
Also called enteral feeding, tube feeding
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.
Standard Enteral NutritionDietary supplement
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Fiber-Enriched Enteral Nutrition | Experimental | Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol. Receives: 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. Receives: Dietary Supplement: Standard Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ICU days 5-7 after admission
Secondary outcomes (7)
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.
Measured: 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.
Measured: Day 14 and 28 after ICU admission
Incidence of Nosocomial Infections
Incidence and type of nosocomial infections occurring during ICU hospitalization.
Measured: 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.
Measured: Day 28 after ICU admission
Duration of ICU and Hospital Stay
Duration of intensive care unit stay and total hospital length of stay.
Measured: 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.
Measured: 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.
Measured: From ICU admission (Day 1) to Day 28 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bacterial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andra-Elena Goicea, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Constantin Bodolea, Study chair, "Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719673
- Sponsor's protocol ID
- DEP227/25.06.2026
- Acronym
- MICRON
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 11688933Koch 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.
PubMed 39511681Andersen 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.
PubMed 40489796O'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.
PubMed 22180847Freedberg 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.
PubMed 32695998Majid 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.
PubMed 24290345Serbanescu 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.
PubMed 41462238Fu 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.
PubMed 31385326Kamarul 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.
PubMed 25954112Krezalek 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.
PubMed 27997410Goicea 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.
PubMed 42324777Choy 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.
PubMed 32733601
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07719673
- Acronym / sponsor ID
- MICRON / DEP227/25.06.2026
- Conditions
- Bacterial Colonization, Multidrug Resistant Organisms, Critical Illness, Gut Microbiota Dysbiosis
- Keywords
- enteral nutrition, bacterial colonization, multidrug resistant organisms, gut microbiota, critical care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber-Enriched Enteral Nutrition | Experimental | Dietary Supplement: Fibre-Enriched Enteral NutritionParticipants will receive an enteral nutrition formula containing dietary fiber according to the study protocol. |
| Standard Enteral Nutrition Without Fiber | Active comparator | Dietary Supplement: Standard Enteral NutritionParticipants will receive an enteral nutrition formula without added dietary fiber according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibre-Enriched Enteral NutritionAlso: enteral feeding, tube feedingParticipants 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 | Fiber-Enriched Enteral Nutrition |
| Standard Enteral NutritionAlso: enteral feeding, tube feedingParticipants 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. | Dietary supplement | Standard Enteral Nutrition Without Fiber |
Primary outcome
Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7
Time frame: 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.
7 secondary outcomes
Change in Gut Microbiota Diversity and Composition
Time frame: From ICU admission (Day 1) to ICU days 5-7
Proportion of Participants With MDRO Colonization at Day 14 and 28
Time frame: Day 14 and 28 after ICU admission
Incidence of Nosocomial Infections
Time frame: From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
Duration of Mechanical Ventilation and Ventilator-Free Days
Time frame: Day 28 after ICU admission
Duration of ICU and Hospital 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
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
Time frame: From ICU admission (Day 1) to Day 28 after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Results publication: PubMed 11688933Caparros 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.
- Results publication: PubMed 39511681Koch 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.
- Results publication: PubMed 40489796Andersen 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.
- Results publication: PubMed 22180847O'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.
- Results publication: PubMed 32695998Freedberg 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.
- Results publication: PubMed 24290345Majid 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.
- Results publication: PubMed 41462238Serbanescu 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.
- Results publication: PubMed 31385326Fu 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.
- Results publication: PubMed 25954112Kamarul 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.
- Results publication: PubMed 27997410Krezalek 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.
- Results publication: PubMed 42324777Goicea 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.
- Results publication: PubMed 32733601Choy 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Constantin Bodolea study chair
"Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibre-Enriched Enteral Nutrition and Standard Enteral Nutrition in people with Bacterial Colonization and Multidrug Resistant Organisms, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Corneliu Leucuța (+40-597256 int 2501, dleucuta@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7 (time frame: ICU days 5-7 after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07719673, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.