The Effect of Probiotic Supplementation on the Incidence of ICU-Acquired Infections Among Enterally Fed Patients: A Single-Center, Randomized, Open-Label, Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of ICU-Acquired Infections.
研究概览
简要总结
This pilot randomized clinical trial investigated the effect of probiotic supplementation on the incidence of intensive care unit-acquired infections (ICU-AIs) in critically ill patients. ICU-AIs are a major complication in patients receiving mechanical ventilation and enteral nutrition, contributing to increased morbidity, prolonged ICU length of stay, and higher mortality rates.
The objective of this study was to assess whether daily administration of a probiotic supplement, in addition to standard ICU care, could reduce the risk of ICU-AIs compared with standard care alone. Eligible participants were critically ill adults who were mechanically ventilated and receiving enteral feeding. Patients were randomly assigned to one of two groups:
Control group: standard ICU care. Intervention group: standard ICU care plus probiotic supplementation (Biopro-max 8 Billion Probiotics (Bioserv Healthcare)).
The intervention continued for 15 days, during which participants were monitored daily for the occurrence of ICU-AIs confirmed by the treating ICU physician. Secondary outcomes included inflammatory and immune markers (CRP, PCT, IgG, IgA), tolerance to enteral feeding, skeletal muscle changes assessed by point-of-care ultrasound, ICU and hospital length of stay, and mortality.
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
- •Enrolled patients were critically ill adults aged 18 years or older, had initiated enteral nutrition (EN) within 48 hours of ICU admission, were required mechanical ventilation and were anticipated to remain ventilated for at least five days.
排除标准
- •Patients were excluded if they had been mechanically ventilated for more than 72 hours before enrollment; had an absolute neutrophil count under 500/mm³; had received antibiotics for more than three days before screening; had received immunosuppressants within one week prior to enrollment or had a diagnosis of immunosuppressive disease; had end-stage cancer; had previously received probiotics, prebiotics, or synbiotics before screening; were pregnant or lactating; or had not received the first dose of probiotics within 48 hours following ICU admission.
研究组 & 干预措施
Arm1: Control Group - Standard ICU Care
Participants in this arm will receive standard ICU care according to institutional protocols. No probiotic supplementation will be administered.
Probiotic Group - Standard Care Plus Biopro-Max
Participants in this arm will receive standard ICU care according to institutional protocols plus Biopro-Max 8 Billion Probiotics (Bioserv Healthcare). The supplement will be administered as one bottle per day for 15 consecutive days.
干预措施: Biopro-max 8 Billion Probiotics (Bioserv Healthcare) (Dietary Supplement)
结局指标
主要结局
Incidence of ICU-Acquired Infections.
时间窗: Within 15 days from enrollment or until ICU discharge, whichever occurs first.
ICU-acquired infections are defined as infections that were not present or detected at ICU admission but occurred during the ICU stay. Infections were confirmed by the attending ICU physician.
次要结局
- Immunoglobulin Levels (IgG and IgA)(Baseline, Day 5, Day 10, and Day 15)
- Inflammatory Marker Levels (CRP and PCT)(Baseline, Day 5, Day 10, and Day 15)
- Enteral Feeding Intolerance(Daily for 15 days or until ICU discharge)
- Muscle wasting(Baseline, Day 5, Day 10, and Day 15)
- Mortality(Within 15 days after enrollment.)
研究者
Aqdar Mufareh Al Aklabi
Principal Investigator, Master's Candidate in Clinical Nutrition, and Clinical Dietitian at Almana Medical Center - Rakah
Imam Abdulrahman Bin Faisal University