Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients (MICRON)
2026年7月20日 更新者：Andra-Elena Goicea、Iuliu Hatieganu University of Medicine and Pharmacy
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:
- 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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Daniel Corneliu Leucuța
- 电话号码：+40-597256 int 2501
- 邮箱：dleucuta@umfcluj.ro
学习地点
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Cluj-Napoca、罗马尼亚
- Emergency Military Clinical Hospital "Dr. Constantin Papilian" Cluj-Napoca
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接触：
- Andra Elena Goicea
- 电话号码：+40723712665
- 邮箱：goiceaandraelena@elearn.umfcluj.ro
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Fiber-Enriched Enteral Nutrition
Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol.
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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.
其他名称：
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有源比较器：Standard Enteral Nutrition Without Fiber
Participants will receive an enteral nutrition formula without added dietary fiber according to the study protocol.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7
大体时间：ICU days 5-7 after admission
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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.
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ICU days 5-7 after admission
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Gut Microbiota Diversity and Composition
大体时间：From ICU admission (Day 1) to ICU days 5-7
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Changes in intestinal microbiota diversity and composition between baseline and follow-up samples, assessed by microbiome analysis of stool samples.
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From ICU admission (Day 1) to ICU days 5-7
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Proportion of Participants With MDRO Colonization at Day 14 and 28
大体时间：Day 14 and 28 after ICU admission
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Proportion of participants with MDRB colonization detected on surveillance microbiological samples among participants who continue receiving enteral nutrition.
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Day 14 and 28 after ICU admission
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Incidence of Nosocomial Infections
大体时间：From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
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Incidence and type of nosocomial infections occurring during ICU hospitalization.
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From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
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Duration of Mechanical Ventilation and Ventilator-Free Days
大体时间：Day 28 after ICU admission
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Duration of invasive mechanical ventilation and number of ventilator-free days during the first 28 days after ICU admission.
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Day 28 after ICU admission
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Duration of ICU and Hospital Stay
大体时间：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.
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Duration of intensive care unit stay and total hospital length of stay.
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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.
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28-Day Mortality and In-Hospital Mortality
大体时间：28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
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All-cause mortality occurring within 28 days after ICU admission and during the index hospital admission.
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28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
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Correlation Between Immunological and Inflammatory Profile Changes and MDRB Colonization or Microbiota Changes
大体时间：From ICU admission (Day 1) to Day 28 after ICU admission
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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.
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From ICU admission (Day 1) to Day 28 after ICU admission
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Constantin Bodolea、"Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年10月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年7月14日
首先提交符合 QC 标准的
2026年7月20日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月20日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- DEP227/25.06.2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.