Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7
时间窗: 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.
次要结局
- 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.)
- 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.)
- Correlation Between Immunological and Inflammatory Profile Changes and MDRB Colonization or Microbiota Changes(From ICU admission (Day 1) to Day 28 after ICU admission)
研究者
Andra-Elena Goicea
Anesthesia and Intensive Care Physician
Iuliu Hatieganu University of Medicine and Pharmacy