Effects of Colostrum Supplement on Inflammatory and Growth Factors, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Occurrence of infection
研究概览
简要总结
Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
详细描述
A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients (>18 years old) admitted to ICU
- •Start of study intervention within 48 hours after ICU admission
- •Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
- •Written informed consent of patient or written informed consent of legal representative
排除标准
- •Enrollment in a related ICU interventional study
- •Requiring other specific enteral nutrition for medical reason
- •Death or Discharge before 5th day
- •Having any contra-indication to receive enteral nutrition
- •Pregnant patients or lactating with the intent to breastfeed
- •BMI <18 or > 40.0 kg/m2
- •Have life expectancy of <6 mo
- •Patients who are moribund
- •History of allergy or intolerance to the study product components
- •Receiving colostrum during two weeks before start study product
- •Have other reasons
研究组 & 干预措施
Colostrum
Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
干预措施: Colostrum (Dietary Supplement)
Maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Occurrence of infection
时间窗: Day 28
次要结局
- 6-month mortality(month 6)
- Length of stay in ICU(Day 28)
- Serum Immunity Markers(baseline, Day 5, Day 10)
- Serum Inflammatory Markers(baseline, Day 5, Day 10)
- 28-day Mortality(Day 28)
研究者
Ghazaleh Eslamian
Principal Investigator
National Nutrition and Food Technology Institute